Blood-thinner Eliquis is getting its committee vote in March, reported Reuters. Drug makers Bristol-Myers Squibb and Pfizer have been trying to get the drug approved for use in patients with atrial fibrillation, but the FDA pushed back in June, saying it wanted more information before making its decision. Reuters noted that the blood thinner market is pegged to be around $10 billion, and an approval would put the drug in a market scrum that includes Bayer/Johnson & Johnson’s Xarelto and Boehringer Ingelheim’s Pradaxa.
The FDA has also set a date to give the COPD drug “FF”/vilanterol “VI” (FF/VI) the once-over in March. Partners GlaxoSmithKline and Theravance announced Wednesday that review requests when out to US and European regulators September 25. FF/VI is delivered through a dry-powder inhaler called Ellipta and has the proposed brand name Brevo in the US and Relvar in Europe and Japan.
On the FDA’s approved-drug list: Bayer’s drug Stivarga among patients with metastic colon cancer. The kinase enzyme inhibitor was approved based on a 760-patient trial that showed a median survival rate of 6.4 months compared with 5 months for patients taking placebo. The trial’s progression-free survival was a median of two months, compared with 1.7 months among placebo recipients. The drug was reviewed under the FDA’s priority review program, and a final vote was expected by October 27 at the latest. Thursday’s approval follows the agency’s go-ahead of the use of Zaltrap with Folfiri for patients with metastic colorectal cancer.
