New Drug News, In Brief
FDA approves Abbott’s Humira for ulcerative colitis and Bayer/Onyx’s regorafenib for colorectal cancer, Bristol-Myers Squibb/Pfizer’s Eliquis faces a St. Patrick’s Day user fee date, and an NEJM poll finds the medical community is evenly split over use of Gilead’s Truvada for HIV pre-exposure prophylaxis.
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Ahead of schedule, FDA approves Stivarga (regorafenib), partnered with Onyx, for late-stage mCRC patients with few options left. Bayer prices drug at under $10,000 a month, on par with competing treatments.
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.
Three-month user fee extension for Bristol-Myers Squibb and Pfizer’s novel oral anticoagulant apixaban raises questions about whether an advisory committee panel will be convened after all, though the companies say none has been scheduled at this time.