Brisk week for the FDA

Two drugs move forward in approval process, two are halted

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SOUTH SAN FRANCISCO—This week has seen mixed results forseveral companies in terms of drug approvals, with two companies walking awaywith positive feedback and two heading back to the drafting table.
Onyx Pharmaceuticals has successfully secured a favorablepanel vote from the U.S. Food and Drug Administration's (FDA) Oncologic DrugsAdvisory Committee, which voted 11-1 (with one abstention) that thebenefit-risk assessment is favorable for the use of Kyprolis (a proposed brandname for carfilzomib), in patients with relapsed and refractory multiplemyeloma who have received at least two prior lines of therapy that include aproteasome inhibitor and an immunomodulatory agent. The Prescription Drug UserFee Act date for the completion of the FDA's review of the Kyprolis new drugapplication for accelerated approval is July 27.
Pfizer also received good news, gaining FDA approval for anadditional indication for its second-best selling drug Lyrica. The drug iscurrently approved for use in treating nerve pain from fibromyalgia, diabeticnerve pain and pain after shingles, and the drug is now approved for use intreating pain caused by spinal cord injuries as well. Lyrica received apriority review designation for the indication from the FDA, the company reported.It is estimated that 270,000 patients have spinal cord injuries in the UnitedStates, and more than 100,000 of those patients in suffer from neuropathic painassociated with the condition.
Not all companies had such a positive week, however. POZEN Inc. announcedthe receipt of an Advice/Information Request letter from the FDA regarding itsulcer drug. After a preliminary review of POZEN's results of a Phase I study todetermine the bioequivalence of PA32540 to enteric-coated aspirin 325 mg usingacetylsalicylic acid as the analyte, the FDA announced that it did not agreethat bioequivalence of PA32540 to enteric-coated aspirin 325 was properlydemonstrated based on the provided information. The FDA also advised thecompany that for the development of a combination product with 81 mg aspirin,an in-vivo bioequivalence study would berequired unless justification for a biowaiver could be provided. The company'sshares fell following the news.
Sanofi also hit a regulatory roadblock with one of itsdrugs. The company failed to move semuloparin, its drug for preventing bloodclots in chemotherapy patients, forward when an FDA panel voted that the drugdoes not provide enough of a benefit to outweigh its risks. The panel voted14-1 against, and supported an FDA staff report released on June 18 that statedthe provided data did not "provide meaningful support for the approval" as avenous thromboembolism treatment for high-risk patients undergoingchemotherapy.
In addition, Celgene Corporation announced that it was withdrawingthe new indication submission to the Committee for Medicinal Products for HumanUse for REVLIMID. The drug was intended for the maintenance treatment of newlydiagnosed multiple myeloma patients who have not progressed following initialtreatment with other options. The company announced that in response to thecommittee's request, it will be resubmitting at a later date with more maturedata.

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