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Brisk week for the FDA
by Kelsey Kaustinen  |  Email the author


SOUTH SAN FRANCISCO—This week has seen mixed results for several companies in terms of drug approvals, with two companies walking away with positive feedback and two heading back to the drafting table.  
Onyx Pharmaceuticals has successfully secured a favorable panel vote from the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee, which voted 11-1 (with one abstention) that the benefit-risk assessment is favorable for the use of Kyprolis (a proposed brand name for carfilzomib), in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that include a proteasome inhibitor and an immunomodulatory agent. The Prescription Drug User Fee Act date for the completion of the FDA's review of the Kyprolis new drug application for accelerated approval is July 27.
Pfizer also received good news, gaining FDA approval for an additional indication for its second-best selling drug Lyrica. The drug is currently approved for use in treating nerve pain from fibromyalgia, diabetic nerve pain and pain after shingles, and the drug is now approved for use in treating pain caused by spinal cord injuries as well. Lyrica received a priority review designation for the indication from the FDA, the company reported. It is estimated that 270,000 patients have spinal cord injuries in the United States, and more than 100,000 of those patients in suffer from neuropathic pain associated with the condition.  
Not all companies had such a positive week, however. POZEN Inc. announced the receipt of an Advice/Information Request letter from the FDA regarding its ulcer drug. After a preliminary review of POZEN's results of a Phase I study to determine the bioequivalence of PA32540 to enteric-coated aspirin 325 mg using acetylsalicylic acid as the analyte, the FDA announced that it did not agree that bioequivalence of PA32540 to enteric-coated aspirin 325 was properly demonstrated based on the provided information. The FDA also advised the company that for the development of a combination product with 81 mg aspirin, an in-vivo bioequivalence study would be required unless justification for a biowaiver could be provided. The company's shares fell following the news.  
Sanofi also hit a regulatory roadblock with one of its drugs. The company failed to move semuloparin, its drug for preventing blood clots in chemotherapy patients, forward when an FDA panel voted that the drug does not provide enough of a benefit to outweigh its risks. The panel voted 14-1 against, and supported an FDA staff report released on June 18 that stated the provided data did not "provide meaningful support for the approval" as a venous thromboembolism treatment for high-risk patients undergoing chemotherapy.
In addition, Celgene Corporation announced that it was withdrawing the new indication submission to the Committee for Medicinal Products for Human Use for REVLIMID. The drug was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with other options. The company announced that in response to the committee's request, it will be resubmitting at a later date with more mature data.
Code: E06211201



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