FDA Offers Up Revised PDUFA Date In June For Takeda’s Alogliptin
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA may be heeding stakeholder calls to set new action dates once an original user fee deadline is missed.
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FDA has set a new action date of June 26, 2009 for Takeda's dipeptidyl peptidase IV inhibitor alogliptin, after missing the original user fee deadline of Oct. 27, the company announced Dec. 24. The revised timeline for the diabetes drug's NDA is surely a disappointment to Takeda, but FDA's willingness to provide a new action date may be reassuring to the industry, which has seen a number of missed user fee dates this year with little guidance from FDA on when action could be anticipated. Some in the industry have called on FDA to communicate a new decision date with a missed user fee deadline to help restore predictability to the process (1 (Also see "FDA Communication On Missed Deadlines Can Help Avoid Drug Review Limbo" - Pink Sheet, 22 Dec, 2008.), p. 7). The increase in missed PDUFA dates this year has been attributed to resource constraints. Some have resulted in a delay of a few weeks in action on a product but other applications have languished for months. A significant delay in approval of alogliptin is a boon for Merck, which sells Januvia (sitagliptin), the only DPP-4 on the market. It could also benefit Bristol-Myers Squibb/AstraZeneca, which submitted an NDA for the investigational DPP-4 Onglyza (saxagliptin) in June, about six months behind Takeda. The delay could open the door for Bristol/AstraZeneca to secure approval of Onglyza first, but then again, FDA action on Onglyza could also be delayed. Takeda had already announced in October that FDA would be unable to complete its review of alogliptin by the original user fee date, citing internal resource constraints. The company indicated that FDA did not raise any issues with data in the application (2 (Also see "Takeda’s Alogliptin Falls Prey To FDA Slowdown" - Pink Sheet, 10 Oct, 2008.)). At the moment, any FDA action on new diabetes drugs is of particular interest as a potential indicator of how the agency might apply its new guidance on cardiovascular safety of diabetes drugs. The guidance, released Dec. 18, requires a sweeping safety review for type 2 diabetes drugs, including studies of cardiovascular mortality, myocardial infarction and stroke (3 (Also see "FDA Diabetes Guidance Encourages Enrollment Of Sicker Patients" - Pink Sheet, 17 Dec, 2008.)). -Jessica Merrill ([email protected]) |