EMA Approval: Jonexa
Jonexa (hylastan) is a bacterially fermented product derived from hyaluronan that is indicated for the treatment of pain associated with OA of the knee and administered in one or two injections. Genzyme expects to launch Jonexa in select European Union markets and Hong Kong in 2010 because they believe opportunity exists in those markets for a lower cost, more convenient OA treatment option than locally available multiple injection products.
For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at [email protected]
FDA Approval: Viibryd
Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year.
“It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”
"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient," said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile."
The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd's antidepressant effect are unknown.
For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at [email protected]
FDA Approval: Brilique
LONDON, Dec 6 (Reuters) - AstraZeneca's new heart medicine Brilique -- or Brilinta -- won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world's second biggest-selling drug, next year.
AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.
The approval by the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in September.
AstraZeneca said that of the European markets that would start selling Brilique in 2011, the majority of launches would occur in the second half of the year due to pricing and reimbursement negotiations.
The drug is recommended for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.
It is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's top-seller Plavix, which had sales last year of more than $9.5 billion, and AstraZeneca will face a tough competitive marketplace, since Plavix is off patent in parts of Europe and loses U.S. patent protection in 2012.
In the United States, where the medicine will be sold as Brilinta, the Food and Drug Administration is due to decide on whether to approve it by Dec. 16. It was endorsed by a U.S. advisory panel in July, despite a perplexing lack of benefit seen among a North American sub-group of patients in a clinical trial that found it was superior to Plavix overall. (Reporting by Ben Hirschler, editing by Kate Kelland)
FDA Approval: Halaven
FDA Approves Eisai Inc. (ESALF.PK)'s Halaven For Late-Stage Breast Cancer
11/15/2010
SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.
Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.
Halaven's safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.
The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."
The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.
Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.
Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.
For more information:
FDA: Office of Oncology Drug Products
NCI: Breast Cancer
Media Inquiries: Erica Jefferson, 301-796-4988, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration