FDA approves Bristol-Myers Squibb’s Eliquis to reduce risk of stroke, blood clots
PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.
Atrial fibrillation — one of the most common types of abnormal heart rhythm — is an abnormal, irregular and rapid beating of the heart in which the heart’s two upper chambers (i.e., atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.
“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.
FDA approves Mylan’s generic Maxalt MLT tablet
PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck’s Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and was awarded 180 days of marketing exclusivity.
"Mylan’s immediate launch of the first generic rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and the company’s simultaneous launch of rizatriptan benzoate tablets, 5 mg and 10 mg, further demonstrates our commitment to continue expanding access to high-quality medicines for patients who need them in the U.S. and around the world. We look forward to continue growing our portfolio of more than 1,100 generic pharmaceutical products to further support this cause," said Mylan CEO Heather Bresch.
Currently, Mylan has 183 ANDAs pending FDA approval, representing $79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ended June 30, 2012, according to IMS Health.
Emergent BioSolutions secures manufacture and sales rights to pandemic influenza vaccine in U.S.
ROCKVILLE, Md. — Emergent BioSolutions on Friday announced that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate’s pandemic influenza vaccine candidate in the United States.
The product candidate, a recombinant vaccine, has the potential to be produced quickly, at high yields and in a cost-effective manner, the company stated. This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority, which established Emergent as a Center for Innovation in Advanced Development and Manufacturing in June 2012.
VaxInnate will continue to develop its pandemic influenza vaccine candidate under its current BARDA contract and Emergent will manufacture the pandemic influenza vaccine candidate using flexible manufacturing technology.