Takeda Pharmaceutical Co faces a delay in getting alogliptin to market after US regulators said that they need more data to evaluate the Japanese drugmaker’s experimental type 2 diabetes drug.
The company’s US subsidiary says it was informed as part of regular discussions with the Food and Drug Administration that although the New Drug Application for alogliptin was filed prior to fresh guidelines laid out by the agency in December, the agency “does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance”.
The FDA issued the updated guidelines on new drugs for treating type 2 diabetes following concerns of cardiovascular risks raised by the use of the diabetes therapies that are already available.
The agency “is open to discussions regarding the design of additional cardiovascular studies” with alogliptin, said Takeda, noting that the Prescription Drug User Fee Act (PDUFA) date that has been scheduled – June 26 – remains unchanged. The FDA had already pushed back its deadline for the review of alogliptin, also known as SYR-322, from the originally scheduled date of October 27 last year, as a result of a lack of resources.
Alogliptin, a dipeptidyl peptidase IV (DPP-4) inhibitor, is seen as vital to the Osaka-based firm’s future success as it prepares for life after the older diabetes blockbuster Actos (pioglitazone), which loses patent protection in the USA in 2011.
By Kevin Grogan
PharmaTimes
Insider's view: the AZ/BMS gliptin will also get snagged. Positive outcome data required!
No comments:
Post a Comment