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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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GSK and Genmab seek alternative approval for leukaemia drug Arzerra
Arzerra
GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.
The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
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Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.
Chronic lymphocytic leukemia (CLL) is a slowly progressing cancer of the blood and bone marrow. Arzerra (ofatumumab) has been approved by the FDA for treating CLL.
Patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy can be prescribed Arzerra.
People older than fifty are mainly affected by CLL. A group of white blood cells known as B-cells that are part of the body’s immune system is the source of CLL. Every year, about ¼ of people diagnosed with CLL die from the disease.
Arzerra is an anti-CD20 monoclonal antibody that targets a membrane-proximal (which means close to the cell surface), small loop epitope, which is a portion of a molecule to which an antibody binds, on the CD20 molecule on B-cells. This epitope isn’t similar to binding sites that are targeted by other CD20 antibodies that are currently available. The CD20 molecule is highly expressed in most B-cell malignancies, making it a key target in CLL therapy.
MECHANISM OF ACTION:
Binding specifically to both the small and large extracellular loops of the CD20 molecule, Arzerra is an anti-CD20 monoclonal antibody. The CD20 molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL. The CD20 molecule isn’t internalized following antibody binding and it isn’t shed from the cell surface. The Fc domain of ofatumumab mediates immune effector functions to result in B-cell lysis in vitro, while the Fab domain binds to the CD20 molecule. Complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity has been suggested as the possible mechanisms of cell lysis.
Products receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live with fewer side effects of a disease or to live longer. Arzerra was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs.
To confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease, the manufacturer of this medication is currently conducting a clinical trial in CLL patients. This is because the accelerated approval process requires further study of the drug.
Epratuzumab
Epratuzumab
Epratuzumab is a humanised anti-CD22 monoclonal antibody under investigation (clinical development phase III) for its efficacy in SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function.
| Expected indication | Systemic lupus erythematosus |
| R&D stage | Phase 3 ongoing (started in December 2010) |
| Next milestone | Phase 3 results (H1 2014) |
| Quick facts |
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Epratuzumab is a humanized monoclonal antibody. Potential uses may be found inoncology and in treatment of inflammatory autoimmune disorders, such as lupus (SLE).[1][2] The manufacturers in August 2009 announced success in early trials against SLE.[3]
Epratuzumab binds to the glycoprotein CD22 of mature and malignant B-cells.
- Epratuzumab, a humanized monoclonal antibody targeting CD22: characterization of in vitro properties Clinical Cancer Research Vol. 9, September 1, 2003 free full text
- Dose-Fractionated Radioimmunotherapy in Non-Hodgkin’s Lymphoma Using DOTA-Conjugated, 90Y-Radiolabeled, Humanized Anti-CD22 Monoclonal Antibody, Epratuzumab Clinical Cancer Research Vol. 11, July 15, 2005 free full text
- Reuters: UCB and Immunomedics Announce Positive Results for Epratuzumab Phase IIb Study in Systemic Lupus Erythematosus (SLE)
Epratuzumab is a humanized IgG1 antibody that acts as an antagonist of the CD22 receptor present on B cells. UCB is currently enrolling patients for the 2 Phase III trials, EMBODY-1 and EMBODY-2. The primary objective of both studies is to measure the percent of subjects meeting treatment response criteria at week 48 among those patients with moderate to severe SLE. Epratuzumab is dosed at either 600 mg per week or 1200 mg every other week administered over four 12-week treatment cycles.
The cumulative dose for both treatment arms is 2400 mg for each of the 4-week dosing periods. The estimated primary completion date is January 2014 for both EMBODY-1 and EMBODY-2. –
UCB pipeline. UCB Web site. www.ucb.com/rd/pipeline/new-development/epratuzumab. Published July 10, 2010. Accessed June 18, 2011
Brussels (Belgium), June 13th 2013, 0700 CEST – UCB today announced new data from an open-label extension (SL0008) of the EMBLEM™ phase 2b study evaluating the long-term effects of epratuzumab treatment in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The primary outcome of the open-label extension was to assess the safety of epratuzumab in patients with SLE.4
Relative to the 12 week, double-blind, placebo-controlled EMBLEM™ study, data from the open-label, long-term extension identified no new safety or tolerability signals.1 In addition, relative to EMBLEM™ baseline values, secondary outcome data indicated that the efficacy of epratuzumab as measured by reduction in disease activity was maintained over two years.2 Secondary outcome data also indicated that relative to EMBLEM™ baseline values, treatment over two years with epratuzumab was associated with decreases in corticosteroid use in patients receiving >7.5 mg/day.1 These data were presented this week at the European League Against Rheumatism 2013 Congress in Madrid, Spain.
Epratuzumab, licensed from Immunomedics Inc. (NASDAQ: IMMU), is an investigational medicine and the first CD-22/B-Cell receptor (BCR) targeted monoclonal antibody to be evaluated in clinical studies for the treatment of SLE. Also known as lupus, SLE is a complex, systemic autoimmune disease that affects many different organ systems, including the skin, joints, lungs, kidneys and blood.3,5
“In EMBLEM™, a dose-ranging, phase 2b study, reduction in disease activity was observed in patients treated with epratuzumab,” said Professor Daniel J Wallace MD, Clinical Professor of Medicine, Cedars-Sinai Medical Center, California, US. “This double-blind study had a relatively short 12-week, placebo-controlled, treatment period and it was important to accumulate long-term data on epratuzumab in the treatment of SLE. The phase 2b extension study adds new two year open-label data on epratuzumab to that already available from the 12-week, randomized, controlled study.”
EMBLEM™ was designed to identify a suitable dosing regimen for epratuzumab.6 A total of 227 patients with moderate-to-severe SLE received either: placebo, epratuzumab cumulative dose of 200 mg (100 mg every other week), 800 mg (400 mg every other week), 2400 mg (600 mg weekly), 2400 mg (1200 mg every other week) or 3600 mg (1800 mg every other week).3,6 In the open-label extension 203 patients from any arm of the EMBELM™ study received 1200 mg epratuzumab at weeks 0 and 2 of 12-week cycles.1,2,7
Data on epratuzumab presented at EULAR 2013
Evaluation of the safety profile of long-term epratuzumab treatment in patients with moderate-to-severe SLE1
Safety variables were primary outcome measures in SL0008 and included duration of exposure, adverse events, infusion reactions and infections.
Exposure to epratuzumab was a median 845 days over a median 10 treatment cycles. Adverse events (AEs) caused discontinuation in 29 (14.3%) patients. The most common serious AEs were SLE flare (3.4%), lupus nephritis (2%) and symptomatic cholelithiasis (1.5%). The most common infections/infestations were urinary tract infection (24.6%) and upper respiratory tract infection (23.2%). There were no opportunistic infections and no patterns of specific serious or severe infections.
Evaluation of long-term efficacy of epratuzumab as measured by reduction in disease activity in patients with moderate-to-severe SLE2
Secondary outcome measures in SL0008 included efficacy as measured by reduction in disease activity, and assessed by: British Isles Lupus Assessment Group (BILAG) improvement, SLE disease activity index (SLEDAI) score, Physician Global Assessment (PGA) score and combined treatment response defined as BILAG improvement without worsening, no SLEDAI worsening and no PGA worsening, relative to EMBLEM™ baseline.
The median BILAG total score was 25.0 at EMBLEM™ baseline and 9.0 at week 108. The score was 14.0 at SL0008 screening. Median SLEDAI score was 12.0 at EMBLEM™ baseline and 4.0 at week 108. The score was 10.0 at SL0008 screening. The median PGA score was 50.0 at EMBLEM™ baseline and 17.5 at week 108 with a score of 31.0 at SL0008 screening.
The proportion of patients achieving the combined treatment response was 32.5% at SL0008 screening (n=203) and 60.3% at week 108 (n=116).
Effect of corticosteroid use of long-term epratuzumab treatment in patients with moderate-to-severe SLE1
Corticosteroid doses were monitored throughout SL0008 and was a secondary outcome measure.
Median corticosteroid dose at EMBLEM™ baseline and SL0008 screening was 10.0 mg/day. At week 116, this was 5 mg/day (n=112). Data indicated that treatment over two years with epratuzumab was associated with decreases in corticosteroid use in patients receiving >7.5 mg/day with a corresponding increase in the proportion of patients receiving lower doses or no longer receiving corticosteroids.
The proportion of patients requiring 7.5-20 mg/day and >20 mg/day decreased (49.8% and 10.8% at baseline and 33.9% and 8.0% respectively, at week 116) and the proportion of patients receiving >0–7.5mg/day or no longer receiving corticosteroids increased (33.5% and 5.9% at baseline and 45.5% and 12.5% respectively, at week 116).
Role of Calcitriol in Cancer-Prevention
Vitamin D is known to play an important role in cancer-prevention. One of the features associated with the onset of malignancy is the elevation of Cu (II) levels. The mode of cancer-prevention mediated by calcitriol, the biologically active form of vitamin D, remain largely unknown.
The current study focused on understanding the role of calcitriol, the biologically active form of Vitamin D, in cancer prevention.
Results indicate that the observed Lipid peroxidation and protein carbonylation (markers of oxidative stress), consequent DNA fragmentation and apoptosis were due to calcitriol-Cu (II) interaction. Hydroxyl radicals, hydrogen peroxide and superoxide anions mediate oxidative stress produced during this interaction. Amongst cellular redox active metals, copper was found to be responsible for this reaction.
And the study concludes by saying that “This is the first report implicating Cu (II) and calcitriol interaction as the cause of selective cytotoxic action of calcitriol against malignant cells.” Study demonstrates that this interaction…
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Sutro Biopharma Prepares for Data Presentation at the World ADC Summit
This year the antibody drug conjugate (ADC) space has taken off like wildfire, with over 30 ADCs now in clinical trials, a number that only continues to grow. Demonstrating this surge of interest, the World ADC Summit will kick off in San Francisco on October 14, featuring leaders in ADC development from more than 40 organizations discussing best practices for designing and developing the optimal ADC.
Trevor Hallam, Ph.D., chief scientific officer of San Francisco-based Sutro Biopharma, will be presenting data at the conference involving an ADC developed using the company’s cell-free protein synthesis technology, at 11 am PT on Tuesday, October 15 in a presentation titled “Producing Homogeneous ADCs with Combination Warheads”.
Sutro’s technology enables hundreds of protein variants to be created and systematically screened, enabling a best-in-class ADC to be selected and significantly shortening development times. In 2012 Sutro formed a partnership with Celgene to develop ADCs…
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Orexigen files obesity drug Contrave for approval in Europe
Orexigen files obesity drug Contrave for approval in Europe
Orexigen Therapeutics has submitted the Marketing Authorization Application (MAA) for Contrave, an investigational weight-loss drug to the European Medicines Agency (EMA).
The La Jolla, CA-based drug firm is using the EMA’s centralised procedure to seek approval for Contrave Orexigen (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. The company filed the application after meeting with the European agency to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. Orexigen and the European regulator have also agreed upon an investigation plan in children and adolescents.
read all at
http://www.pharmatopics.com/2013/10/orexigen-files-obesity-drug-contrave-approval-europe/
FDA Approves Pfizer’s Duavee
Pfizer Inc. Announces FDA Approval Of DUAVEETM (conjugated estrogens/ bazedoxifene) For The Treatment Of Moderate-To-Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause And The Prevention Of Postmenopausal Osteoporosis
DUAVEE is the first and only therapy to pair conjugated estrogens with an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator (SERM) [2]
Thursday, October 3, 2013 – 4:14pm EDT
NEW YORK, N.Y., October 3 – Pfizer Inc. (NYSE: PFE), a leader in the development of treatments for menopausal symptoms, is pleased to announce that the United States Food and Drug Administration (FDA) has approved DUAVEETM (conjugated estrogens/bazedoxifene) 0.45mg / 20mg tablets, a novel therapy for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis
read all http://www.pharmalive.com/fda-approves-pfizer-s-duavee
PharmaPortugal, INFARMED and APIFARMA sign agreement to promote exportation of medicines
October 04 ,2013 | By Márcio Barra
INFARMED has announced that PharmaPortugal, a partnership between INFARMED, the Portuguese National Authority of Medicines, and APIFARMA, the Portuguese Association of the Pharmaceutical Industry, signed an agreement to promote the exports and internationalization of Portugal based Pharmaceutical companies.
Under this protocol, PharmaPortugal and INFARMED are to combine efforts to increase the value of exports from Portugal, by working on the already existing markets while opening new ones, and promoting the Portuguese industry and the quality of its medicines in overseas markets. This protocol will last two years, during which pharmaceutical companies that partake in PharmaPortugal are to identify priority markets, encourage cooperation among themselves and contribute to the development of its products through collaboration with external research entities and universities.
Moreover, under the protocol, INFARMED is to streamline and simplify the national procedures required for the exportation of medicines, including certificates of good manufacturing…
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Tetraphase to Present New Data at IDWeek on Eravacycline’s Potential Activity in Treating Serious Respiratory Infections
eravacycline
http://www.ama-assn.org/resources/doc/usan/eravacycline.pdf
1-Pyrrolidineacetamide, N-[(5aR,6aS,7S,10aS)-9-(aminocarbonyl)-7-(dimethylamino)-
4-fluoro-5,5a,6,6a,7,10,10a,12-octahydro-1,8,10a,11-tetrahydroxy-10,12-dioxo-2-
naphthacenyl]-
(4S,4aS,5aR,12aS)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-
[(pyrrolidin-1-ylacetyl)amino]-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
MOLECULAR FORMULA C27H31FN4O8
MOLECULAR WEIGHT 558.6
SPONSOR Tetraphase Pharmaceuticals, Inc.
CODE DESIGNATION TP-434
CAS REGISTRY NUMBER 1207283-85-9
WHO NUMBER 9702
Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) today announced that it will present two posters at IDWeek 2013 that examine the potential of its lead antibiotic candidate eravacycline to treat serious multi-drug resistant (MDR) infections. The first will highlight positive results of a Phase 1 study assessing the bronchopulmonary disposition safety and tolerability of eravacycline in healthy men and women; this study represents the first clinical assessment of eravacycline for potential use in treating pneumonia. The second poster will provide the results of a study that examined the activity of eravacycline in vitro against multiple Gram-negative and Gram-positive pathogens to set quality-control limits for monitoring eravacycline activity in future testing programs.
http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=79335#.Uk6MOoanonU
More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=79335#.Uk6MOoanonU#ixzz2gkEMTtQm
Eravacycline (TP-434) is a synthetic fluorocycline antibiotic in development.
Eravacycline (TP-434 or 7-fluoro-9-pyrrolidinoacetamido-6-demethyl-6-deoxytetracycline) is a novel fluorocycline that was evaluated for antimicrobial activity against panels of recent aerobic and anaerobic Gram-negative and Gram-positive bacteria. Eravacycline showed potent broad spectrum activity against 90% of the isolates (MIC90) in each panel at concentrations ranging from ≤0.008 to 2 μg/mL for all species panels except Pseudomonas aeruginosa and Burkholderia cenocepacia (MIC90 values of 32 μg/mL for both organisms). The antibacterial activity of eravacycline was minimally affected by expression of tetracycline-specific efflux and ribosomal protection mechanisms in clinical isolates. Further, eravacycline was active against multidrug-resistant bacteria, including those expressing extended spectrum β-lactamases and mechanisms conferring resistance to other classes of antibiotics, including carbapenem resistance. Eravacycline has the potential to be a promising new IV/oral antibiotic for the empiric treatment of complicated hospital/healthcare infections and moderate-to-severe community-acquired infections.
Tetraphase’s lead product candidate, eravacycline, has also received an award from Biomedical Advanced Research and Development Authority (BARDA) that provides for funding to develop eravacycline as a potential counter-measure to certain biothreat pathogens. It is worth up to USD 67 million.
Process R&D of Eravacycline: The First Fully Synthetic Fluorocycline in Clinical Development
Eravacycline (TP-434)
We are developing our lead product candidate, eravacycline, as a broad-spectrum intravenous and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multi-drug resistant (MDR) infections, including MDR Gram-negative bacteria. We developed eravacycline using our proprietary chemistry technology. We completed a successful Phase 2 clinical trial of eravacycline with intravenous administration for the treatment of patients with complicated intra-abdominal infections (cIAI) and have initiated the Phase 3 clinical program.
Eravacycline is a novel, fully synthetic tetracycline antibiotic. We selected eravacycline for development from tetracycline derivatives that we generated using our proprietary chemistry technology on the basis of the following characteristics of the compound that we observed in in vitro studies of the compound:
- potent antibacterial activity against a broad spectrum of susceptible and multi-drug resistant bacteria, including Gram-negative, Gram-positive, atypical and anaerobic bacteria;
- potential to treat the majority of patients as a first-line empiric monotherapy with convenient dosing; and
- potential for intravenous-to-oral step-down therapy.
In in vitro studies, eravacycline has been highly active against emerging multi-drug resistant pathogens like Acinetobacter baumannii as well as clinically important species ofEnterobacteriaceae, including those isolates that produce ESBLs or are resistant to the carbapenem class of antibiotics, and anaerobes.
Based on in vitro studies we have completed, eravacycline shares a similar potency profile with carbapenems except that it more broadly covers Gram-positive pathogens like MRSA and enterococci, is active against carbapenem-resistant Gram-negative bacteria and unlike carbapenems like Primaxin and Merrem is not active against Pseudomanas aeruginosa. Eravacycline has demonstrated strong activity in vitro against Gram-positive pathogens, including both nosocomial and community-acquired methicillin susceptible or resistantStaphylococcus aureus strains, vancomycin susceptible or resistant Enterococcus faecium andEnterococcus faecalis, and penicillin susceptible or resistant strains of Streptococcus pneumoniae. In in vitro studies for cIAI, eravacycline consistently exhibited strong activity against enterococci and streptococci. One of the most frequently isolated anaerobic pathogens in cIAI, either as the sole pathogen or often in conjunction with another Gram-negative bacterium, is Bacteroides fragilis. In these studies eravacycline demonstrated activity against Bacteroides fragilis and a wide range of Gram-positive and Gram-negative anaerobes.
Key Differentiating Attributes of Eravacycline
The following key attributes of eravacycline, observed in clinical trials and preclinical studies of eravacycline, differentiate eravacycline from other antibiotics targeting multi-drug resistant infections, including multi-drug resistant Gram-negative infections. These attributes will make eravacycline a safe and effective treatment for cIAI, cUTI and other serious and life-threatening infections for which we may develop eravacycline, such as ABSSSI and acute bacterial pneumonias.
- Broad-spectrum activity against a wide variety of multi-drug resistant Gram-negative, Gram-positive and anaerobic bacteria. In our recently completed Phase 2 clinical trial of the intravenous formulation of eravacycline, eravacycline demonstrated a high cure rate against a wide variety of multi-drug resistant Gram-negative, Gram-positive and anaerobic bacteria. In addition, in in vitro studies eravacycline demonstrated potent antibacterial activity against Gram-negative bacteria, including E. coli; ESBL-producing Klebsiella pneumoniae; Acinetobacter baumannii; Gram-positive bacteria, including MSRA and vancomycin-resistant enterococcus, or VRE; and anaerobic pathogens. As a result of this broad-spectrum coverage, eravacycline has the potential to be used as a first-line empiric monotherapy for the treatment of cIAI, cUTI, ABSSSI, acute bacterial pneumonias and other serious and life-threatening infections.
- Favorable safety and tolerability profile. Eravacycline has been evaluated in more than 250 subjects in the Phase 1 and Phase 2 clinical trials that we have conducted. In these trials, eravacycline demonstrated a favorable safety and tolerability profile. In our recent Phase 2 clinical trial of eravacycline, no patients suffered any serious adverse events, and safety and tolerability were comparable to ertapenem, the control therapy in the trial. In addition, in the Phase 2 clinical trial, the rate at which gastrointestinal adverse events such as nausea and vomiting that occurred in the eravacycline arms was comparable to the rate of such events in the ertapenem arm of the trial.
- Convenient dosing regimen. In our recently completed Phase 2 clinical trial we dosed eravacycline once or twice a day as a monotherapy. Eravacycline will be able to be administered as a first-line empiric monotherapy with once- or twice-daily dosing, avoiding the need for complicated dosing regimens typical of multi-drug cocktails and the increased risk of negative drug-drug interactions inherent to multi-drug cocktails.
- Potential for convenient intravenous-to-oral step-down. In addition to the intravenous formulation of eravacycline, we are also developing an oral formulation of eravacycline. If successful, this oral formulation would enable patients who begin intravenous treatment with eravacycline in the hospital setting to transition to oral dosing of eravacycline either in hospital or upon patient discharge for convenient home-based care. The availability of both intravenous and oral administration and the oral step-down will reduce the length of a patient’s hospital stay and the overall cost of care.
Additionally, in February 2012, Tetraphase announced a contract award from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $67 million for the development of eravacycline, from which Tetraphase may receive up to approximately $40 million in funding. The contract includes pre-clinical efficacy and toxicology studies; clinical studies; manufacturing activities; and associated regulatory activities to position the broad-spectrum antibiotic eravacycline as a potential empiric countermeasure for the treatment of inhalational disease caused by Bacillus anthracis, Francisella tularensis and Yersinia pestis.\
……………………………………………………………………………………….
Process research and development of the first fully synthetic broad spectrum 7-fluorotetracycline in clinical development is described. The process utilizes two key intermediates in a convergent approach. The key transformation is a Michael–Dieckmann reaction between a suitable substituted aromatic moiety and a key cyclohexenone derivative. Subsequent deprotection and acylation provide the desired active pharmaceutical ingredient in good overall yield.
Process R&D of Eravacycline: The First Fully Synthetic Fluorocycline in Clinical Development
FDA Grants QIDP Designation to Eravacycline, Tetraphase’s Lead Antibiotic Product Candidate
– Eravacycline designated as a QIDP for complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI) indications –
July 15, 2013 08:30 AM Eastern Daylight Time
WATERTOWN, Mass.–(BUSINESS WIRE)–Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s lead antibiotic product candidate, eravacycline, as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI) indications, will make eravacycline eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, eravacycline is eligible for an additional five-year extension of Hatch-Waxman exclusivity.
Vitamin B2- Riboflavin
Next up in our vitamin march is Vitamin B2, also known as riboflavin. Riboflavin in our diet mostly comes from meat, dairy products, eggs, green leafy vegetables, almonds, or mushrooms. Yeast, liver, and kidney are particularly rich in riboflavin. Also, like thiamine riboflavin is found in cereal grains such as wheat and rice but again is mostly in the outer portion or the germ and therefore much of it is lost in processed grains (yet again, it is important to eat whole grains when possible). Riboflavin is easily destroyed by UV light so some recommend buying dairy products in containers that do not allow light to pass through.
This is the vitamin that gives your urine that neon yellow appearance if you take B vitamin supplements or a multivitamin with high doses of riboflavin. Riboflavin is important for energy metabolism and is required in the processing of other vitamins including Vitamin A…
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New Drug Approvals 