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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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New study reveals Iron supplementation may help Velcade work better
bortezomib
read at
Bortezomib (INN, originally codenamed PS-341; marketed as Velcade by Millennium Pharmaceuticals) is the first therapeutic proteasome inhibitor to be tested in humans. It is approved in the U.S. for treating relapsed multiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.
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Bortezomib was originally synthesized in 1995 (MG-341) at a company called Myogenics, which soon changed its name to ProScript. After promising preclinical results, the drug (PS-341) was tested in a small Phase I clinical trial on patients with multiple myeloma cancer. ProScript ran out of money and was bought by Leukosite in May 1999. Leukosite in turn was bought by Millennium Pharmaceuticals in October 1999. At this point in time, the project had low priority amongst other projects at the company. This changed significantly when one of the first volunteers to receive the drug in the clinical trial achieved a complete response and were still alive four years later. At the time this was a remarkable result. Later clinical experimentation indicates the possibility of a complete response in 15% of patients in a similar condition, when treated with bortezomib.
In May 2003, seven years after the initial synthesis, bortezomib (Velcade) was approved in the United States by the Food and Drug Administration (FDA) for use in multiple myeloma, based on the results from the SUMMIT Phase II trial.
Another commercially available bortezomib product – Bortenat (Natco Pharma, India), reportedly contains substantially more active entity than declared, potentially and even more resulting in increase toxicity. Moreover, Bortenat has some other chemical and formulation deviations from the registered ethic product Velcade (Millennium Pharmaceuticals and Janssen-Cilag), with unclear clinical impact.
Pharmacology
Bortezomib bound to the core particle in a yeast proteasome. The bortezomib molecule is in the center colored by atom type (boron = pink, carbon = cyan, nitrogen = blue, oxygen = red), surrounded by the local protein surface. The blue patch is catalytic threonine residue whose activity is blocked by the presence of bortezomib.
Structure
The drug is an N-protected dipeptide and can be written as Pyz-Phe-boroLeu, which stands for pyrazinoic acid, phenylalanine and Leucine with a boronic acid instead of a carboxylic acid. Peptides are written N-terminus to C-terminus, and this convention is used here even though the “C-terminus” is a boronic acid instead of a carboxylic acid.
FDA panel urges looser restrictions on diabetes drug Avandia
june 6 2013,
The controversial diabetes drug Avandia will get a second look from federal regulators this week, nearly two years after its use was severely restricted because of a link to heart problems.
The U.S. Food and Drug Administration has convened a panel of experts to consider an independent review by Duke University researchers of Avandia’s original clinical trial. The expert panel will conclude its sessions on Thursday, and could decide to alter or even lift the tight restrictions now in place regarding the medication’s use.
The Duke scientists did uncover some previously unreported cases of heart complications and deaths, but concluded that these cases did not significantly raise the overall risk of heart disease and the conclusions of the original trial still hold.
The FDA’s reconsideration of Avandia’s safety has prompted stinging criticism from the drug’s detractors, who say the agency is trying to save face following a very public embarrassment over the drug.
“This is a drug that has essentially been off the market in almost the entire world for the last three years. It has been banned in most countries, and is available in the United States under such strict requirements that only 3,000 patients now take it,” said Dr. Steven Nissen, the Cleveland Clinic cardiologist who first led the charge against Avandia. “It’s really about the FDA wanting to clean up its image, not about whether the drug is actually safe or unsafe.”
The FDA has defended its decision to review the Duke re-analysis of the original trial, which was conducted by the drug’s maker, GlaxoSmithKline, under the name Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD).
“Given the public interest in Avandia, the extensive history of the product and the continued uncertainty of risk, the FDA is holding the advisory committee meeting to have a transparent, public discussion of the results of the RECORD readjudication,” FDA spokesperson Morgan Liscinsky said.
Avandia quickly became a blockbuster diabetes drug following its release in 1999, with sales topping $3 billion in 2006.
Nutrient Found in Mediterranean Diet Shown to Promote Natural Cancer Cell Death Cycle
Volumes of well documented scientific studies now provide conclusive evidence that many forms of potentially deadly cancers develop as the result of dietary or lifestyle influences, and can be prevented or even treated with relatively simple modifications and by utilizing a host of natural nutrients. One of the primary methods used by cancer cells to develop and spread is a unique ability to ‘trick’ our innate immune response and avoid elimination through the natural process known as apoptosis.
A research team from the University of Ohio, publishing the results of a study in the Proceedings of the National Academy of Sciences has found that a compound abundant in the Mediterranean diet takes away cancer cells’ ‘superpower’ to escape death. Scientists discovered that by altering a very specific step in gene regulation, this compound essentially re-educates cancer cells to revert back to normal cells that die as scheduled. The compound…
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Mayo Clinic – Ginseng Fights Fatigue in Cancer Patients, Mayo Clinic-Led Study Finds
High doses of the herb American ginseng (Panax quinquefolius) over two months reduced cancer-related fatigue in patients more effectively than a placebo, a Mayo Clinic-led study found. Sixty percent of patients studied had breast cancer. The findings are being presented at the American Society of Clinical Oncology’s annual meeting.
via Mayo Clinic – Ginseng Fights Fatigue in Cancer Patients, Mayo Clinic-Led Study Finds.
Eisai Announces Availability of BELVIQ® (lorcaserin HCl) CIV Tablets for Chronic Weight Management in Adults who are Overweight with a Comorbidity or Obese BELVIQ Available in U.S. Pharmacies within One Week
LORCASERIN
june 7, 2013 –Eisai Inc. announced today that BELVIQ (pronounced BEL-VEEK) will be available to eligible patients by prescription in the United States beginning June 11.
BELVIQ was approved by the U.S. Food and Drug Administration on June 27, 2012 to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes your risk of heart problems or stroke, or of death due to heart problems or stroke.
“BELVIQ is a new treatment option for the medical management of patients who are obese and who have not been able to sustain long-term weight loss by altering their diets or increasing exercise alone,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “Eisai is committed to making BELVIQ available to appropriate patients as part of our human health care corporate mission of keeping patients’ medical needs at the forefront of all that we do.”
BELVIQ will be available in U.S. pharmacies only with a prescription. Patients are cautioned not to buy BELVIQ from parties offering BELVIQ without a valid prescription from their doctor. Eisai will market and distribute BELVIQ in the United States and Arena Pharmaceuticals will manufacture and supply the finished commercial product from its facility in Switzerland.
“BELVIQ provides appropriate patients with a new treatment option that along with diet and exercise can help them lose weight and keep the weight off,” said Ken Fujioka, M.D., Director of the Center for Weight Management at the Scripps Clinic. “Obesity needs to be recognized and treated as a chronic disease. The availability of BELVIQ is a significant milestone in the medical management of overweight and obesity as we work to slow this epidemic in the United States.”
Lorcaserin (APD-356, trade name upon approval Belviq,expected trade name during development, Lorqess) is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic. On 22 December 2009 a New Drug Application (NDA) was submitted to the Food and Drug Administration (FDA) in the United States.On 16 September 2010, an FDA advisory panel voted to recommend against approval of the drug based on concerns over both safety and efficacy. In October 2010, the FDA stated that it could not approve the application for lorcaserin in its present form.
On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity like high blood pressure or type 2 diabetes.
On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who “have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol”.
On 07 May 2013, the US Drug Enforcement Administration has classified lorcaserin as a Schedule IV drug[10] under the Controlled Substances Act.
About BELVIQ (lorcaserin HCl) CIV Tablets
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence. For more information about BELVIQ,
Joint Pain: Medicine Kit of the Lower Pecos, Part II
Human beings have been plagued with joint pain throughout the history of mankind. Arthritis, the condition caused by the wearing down of beneficial cartilage in the joints, affects over 27 million people in the United States today, according to the Arthritis Foundation
(www.arthritistoday.org). I don’t know enough about the skeletal evidence from the Lower Pecos of Texas to do more than speculate, but at least some people in the region 4000-6000 years ago must have worn out a knee or two climbing up and down steep canyons and running over rough stone outcroppings in the uplands. In other words, they probably had their share of “archaic arthritis.”
Ow! Even that phrase hurts! Osteoarthritis produces stinging pain and can cause swelling and stiffness in the joints affected. Generally, the older you are, the more wear and tear you have on your joints. A stiff knee could make a thirty-year-old adult from the archaic period feel…
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Idenix Pharmaceuticals Announces Samatasvir (IDX719) Poster Presentations at the Asian Pacific Association for the Study of the Liver (APASL) Conference
New Hepititis C Virus Therapy
Idenix Pharmaceuticals Announces Samatasvir (IDX719) Poster Presentations at …
Wall Street Journal JUNE 6, 2013
… Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced three poster presentations featuring clinical and preclinical data for samatasvir (IDX719), …
READ ALL AT
http://online.wsj.com/article/PR-CO-20130606-905746.html
Idenix Pharmaceuticals, the Cambridge-based biotechnology company, announced that their drug, IDX719, was granted a Fast Track designation by the FDA. IDX719, an NS5A inhibitor, is designed to treat chronic hepatitis C virus (HCV) infection in patients. The Fast Track designation will enable Idenix Pharmaceuticals to shave precious time off their predicted timeline for a new drug application (NDA), and even increase interaction with the FDA to guarantee a quicker review and a shorter time to market.
Tasimelteon
Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
WASHINGTON, June 5, 2013 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) presented additional entrainment and patient-level clinical data at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals. Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (synchronize) their master body clock to the 24-hour day. Currently there is no approved FDA treatment for Non-24.
In the SET study, tasimelteon achieved the primary endpoints of entrainment (synchronizing) of the melatonin (aMT6s) rhythm as compared to placebo and clinical…
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Biocon Seeks Partner to Sell Rival Drug to J J’s Stelara
Managing Director Kiran Mazumdar-Shaw, BIOCON
Photographer-Namas Bhojani/Bloomberg
Rapid commercialization of Alzumab “will be transformational for us,” said Kiran Mazumdar-Shaw, chairman and managing director of Biocon Ltd.
Managing Director Kiran Mazumdar-Shaw, is seeking a partner to help with expertise and funding for the tests needed for approval in the U.S., she said in an interview. Biocon plans to file for permission in the year ending March to sell in the North American nation, and aims to start marketing Alzumab in that country two to three years later, she said.
Alzumab would provide a novel therapy for a plaque-causing form of the immune disorder that would compete with best-selling products from Johnson & Johnson, AbbVie Inc. and Pfizer Inc. (PFE) The biologic psoriasis treatment, made from living cells, will help Biocon enter a market that it estimates will be valued at $8 billion by 2016.
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http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5630
Itolizumab (Alzumab) is a ‘first in class’ humanized IgG1 monoclonal antibody developed by Biocon. It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation.[1] A double blind, placebo controlled, phase III treat –Plaq study of Itolizumab, successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[2] Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).[3]
- http://www.biocon.com/docs/PR_080113.pdf?subLink=news
- http://www.thehindubusinessline.com/companies/article2789996.ece
- http://www.pharmabiz.com/NewsDetails.aspx?aid=73075&sid=2
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