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Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) say that it launched its novel Parkinson’s disease drug Nouriast (istradefylline) in Japan on May 30.
Istradefylline (KW-6002), 8-[(E)-2-(3,4-dimethoxyphenyl)vinyl]-1,3-diethyl-7-methyl-3,7-dihydro-1H-purine-2,6-dione, is a selective antagonist at the A2A receptor. It has been found to be useful in the treatment of Parkinson’s disease.[1] Istradefylline reduces dyskinesia resulting from long-term treatment with classical antiparkinson drugs such as levodopa. Istradefylline is an analog of caffeine.
1–
- Peter A. LeWitt, MD, M. Guttman, James W. Tetrud, MD, Paul J. Tuite, MD, Akihisa Mori, PhD, Philip Chaikin, PharmD, MD, Neil M. Sussman, MD (2008). “Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces off time in Parkinson’s disease: A double-blind, randomized, multicenter clinical trial (6002-US-005)”. Annals of Neurology 63 (3): 295–302. doi:10.1002/ana.21315. PMID 18306243.
Nouriast, which is the world’s first anti-parkinsonian agent of a first-in-class adenosine A2A receptor antagonist, was listed on the National Health Insurance Drug Price List on May 24, 2013 after the manufacturing and marketing approval in Japan on March 25, the company noted. In clinical trials in Japan, Nouriast improved wearing-off phenomena and was well tolerated in Parkinson’s disease patients
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Novartis Japan Achieves Primary Endpoint In HER2 Positive Advanced Breast Cancer Phase III Afinitor Trials
Everolimus
Novartis announced it achieved its primary endpoint of significantly extending progression-free survival with Afinitor (everolimus) in Phase III trials of patients with HER2 positive advanced breast cancer.
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Everolimus (RAD-001) is the 40-O-(2-hydroxyethyl) derivative of sirolimus and works similarly to sirolimus as an inhibitor of mammalian target of rapamycin (mTOR).
It is currently used as an immunosuppressant to prevent rejection of organ transplants and treatment of renal cell cancer and other tumours. Much research has also been conducted on everolimus and other mTOR inhibitors for use in a number of cancers.
It is marketed by Novartis under the tradenames Zortress (USA) and Certican (Europe and other countries) in transplantation medicine, and Afinitor in oncology.
Kyowa Hakko Kirin, has received approval for NOURIAST tablets 20 mg (istradefylline), a novel antiparkinsonian agent, has been approved for manufacturing and marketing in Japan
Istradefylline (KW-6002) is a selective antagonist at the A2A receptor. It has been found to be useful in the treatment of Parkinson’s disease.[1] Istradefylline reduces dyskinesia resulting from long-term treatment with classical antiparkinson drugs such as levodopa. Istradefylline is an analog of caffeine.
References
Peter A. LeWitt, MD, M. Guttman, James W. Tetrud, MD, Paul J. Tuite, MD, Akihisa Mori, PhD, Philip Chaikin, PharmD, MD, Neil M. Sussman, MD (2008). “Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces off time in Parkinson’s disease: A double-blind, randomized, multicenter clinical trial (6002-US-005)”. Annals of Neurology 63 (3): 295–302. doi:10.1002/ana.21315. PMID 18306243.
TUE 26 MAR 2013
Nippon and Teva receive approval for biosimilar G-CSF (fligrastim) in Japan
As with the original drug, acts on neutrophil precursor cells, to promote the proliferation, differentiation and its biosimilar filgrastim of (recombinant) promotes the release of neutrophils from the bone marrow, enhances its function. In the field of cancer treatment, it is used for chemotherapy-induced neutropenia mainly cancer.
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes.[1] It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is different from G-CSF naturally made in humans.
It is marketed by Amgen under the brand name Neupogen, in India it is also marketed by Abbott Healthcare under the brand name Imumax, Dr. Reddy’s Laboratories under the brand name Grafeel, In Pakistan CCL Pharmaceuticals (Pvt) Ltd under the brand name Grastin, Zenotech Laboratories Limited under the brand name Nugraf, Raichem lifesciences under the brand name Shilgrast, Intas Biopharmaceuticals under the brand name Neukine, Emcure biopharmaceuticals under the brand name Emgrast, Reliance Life Sciences under the brand name Religrast and Sandoz under the name Zarzio.
Apricus Biosciences is currently developing and testing a product (under the brand name Nupen) which can deliver filgrastim through the skin to improve post-chemotherapy recovery of neutrophil counts.
Takeda Submits Marketing Authorisation Application for Vedolizumab in Moderately to Severely Active Ulcerative Colitis and Crohn’s Disease in the European Union
March 7, 2013
Pharmaceutical Company Limited (“Takeda”) today announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would be the first and only gut-selective biologic agent for UC and CD on the market.
“Ulcerative colitis and Crohn’s disease are chronic debilitating diseases with important unmet medical needs, often affecting young people in the prime of their lives,” said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. “We are encouraged by the findings of GEMINI, the vedolizumab Phase 3 clinical development program, which studied approximately 3,000 patients in nearly 40 countries, making it the largest IBD clinical trial program conducted to date.”
Nearly four million people worldwide are affected by IBD, with UC affecting more than 500,000 people and CD affecting approximately 230,000 people in the EU. Crohn’s disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve varying areas of the digestive tract, while UC impacts the colon only. CD and UC can be both painful and debilitating, which may sometimes lead to serious complications and can significantly impact the quality of life for patients.
The MAA submission was supported by Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which are part of the GEMINI Studies™, a four-study clinical research program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients, who had failed at least one conventional or anti-TNFα therapy.
“With a targeted mechanism of action, vedolizumab has clinical promise as a potential treatment option for people with moderate to severely active CD and UC,” said Paul Rutgeerts, M.D., Ph.D., F.R.C.P., professor of medicine, Catholic University of Leuven, Belgium. “While there is no known cure, there is a need for new CD and UC treatment options, in an effort to provide patients with additional choices for managing their disease, reducing symptoms and achieving remission.”
About Crohn’s disease and ulcerative colitis
Crohn’s disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the lining of the GI tract. CD can impact any part of the digestive tract, and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and/or fever. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. There is no known cause for CD or UC, although many researchers believe that the interaction of an outside agent, such as a virus or bacteria, with the body’s immune system may trigger them. No cure exists for CD or UC; the aim of IBD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.
About vedolizumab
Vedolizumab was developed for the treatment of CD and UC, as a gut-selective, humanized monoclonal antibody that specifically antagonizes the alpha4beta7 (α4β7) integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in CD and UC. α4β7 binds with a specific adhesion molecule primarily expressed in the intestinal tract. Therefore, vedolizumab, by preventing this interaction, has a gut selective effect.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com.
Vedolizumab is a monoclonal antibody being developed by Millennium Pharmaceuticals, Inc. for the treatment of ulcerative colitis and Crohn’s disease.It binds to integrin α4β7(LPAM-1, lymphocyte Peyer’s patch adhesion molecule 1).[1][2]
The molecule was first identified by Dr. Andrew Lazarovits [1][2] as the murine MLN0002 homologue. His discovery of the mouse equivalent of this antibody—originally applied to anti-rejection strategies in kidney transplantation—was published in the journal Nature in 1996. The drug was then licensed to Millennium Pharmaceuticals of Boston for further development.
As of October 2009, vedolizumab is undergoing Phase III trials.[3] Clinical trials indicate that Vedolizumab was found safe and highly effective for inducing and maintaining clinical remission in patients with moderate to severe ulcerative colitis [3]. Dr. Brian Faegan, head researcher, reported an absence of any instances of progressive multifocal leukoencephalopathy (PML), which is a particularly important finding [4]. It looks like it will be an effective abiologic agent without some of the toxicity issues previously seen with anti-TNF drugs .
It is widely believed now that “vedolizumab can be used either as a first-line treatment or in case of anti-TNF failure”
- Statement On A Nonproprietary Name Adopted By The USAN Council – Vedolizumab, American Medical Association.
- Soler, D; Chapman, T; Yang, LL; Wyant, T; Egan, R; Fedyk, ER (2009). “The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases”. The Journal of Pharmacology and Experimental Therapeutics 330 (3): 864–75. doi:10.1124/jpet.109.153973. PMID 19509315.
- ClinicalTrials.gov NCT00790933 Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn’s Disease (GEMINI II)
ONO Pharmaceutcal files for approval of Additional Indication for Onoact® 50 injection, Short-Acting Selective β1 Blocker in Japan
disease. AF/AFL with LV dysfunction accompanying by persistent elevated heart rate would lead to further deterioration of cardiac performance. Swift rate control is inevitable to be restored from this detrimental condition, however, no drug on market can provide both the features of fast-acting and easy titratability for tachyarrhythmia (AF/AFL) with LV dysfunction.
Onoact® 50 for injection is the short-acting selective β1 blocker which reduces heart rate by selectively blocking β1 receptors located chiefly in the heart and this fast-acting drug can be easily titrated.
We expect that Onoact® 50 for injection can contribute to promptly reducing heart rate without causing deterioration of cardiac performance in treatment of tachyarrhythmia (AF/AFL) with LV dysfunction.
This short-acting selective β1 blocker drug is discovered and developed by ONO and has been widely used by many patients since its launch. The drug has firstly received approval for emergency treatment of intra-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) in July 2002. Then, it had also been approved for additional indication of emergency treatment of post-operative tachyarrhythmia (atrial fibrillation and flutter, and sinus tachycardia) with monitoring of circulatory dynamics in October 2006.
| Identifiers | |
|---|---|
| CAS number | 133242-30-5 |
| Chemical data | |
| Formula | C25H39N3O8 |
| Mol. mass | 509.59 g/mol |
Landiolol (INN) is a drug which acts as a highly cardioselective, ultra short-acting beta blocker. It is used as an anti-arrhythmic agent.
- Yoshiya I (December 1998). “[Landiolol hydrochloride, a new sympathetic beta blocker]” (in Japanese). Masui 47 Suppl: S126–32. PMID 9921175.
- Ogata J, Okamoto T, Minami K (2003). “Landiolol for the treatment of tachyarrhythmia associated with atrial fibrillation”. Can J Anaesth 50 (7): 753. doi:10.1007/BF03018726. PMID 12944459
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