FDA to evaluate Takeda diabetes drug CV risk on 2008 guidance
Takeda Global Research and Development Center, a wholly owned subsidiary of Takeda Pharmaceutical, was informed that although its alogliptin new drug application (NDA) was filed prior to issuance of the FDA's December 2008 guidance on new type 2 diabetes treatments, the FDA will apply the guidelines when reviewing the alogliptin NDA.
In the 2008 guidance, the FDA recommended that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular (CV) events as a heart attack.
In its correspondence with Takeda, the FDA also said that it does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency said it is open to discussions regarding the design of additional CV studies with alogliptin. They added that alogliptin's Prescription Drug User Fee Act (PDUFA) date of June 26, 2009 remains unchanged.
Takeda originally submitted its NDA for alogliptin to the FDA in December 2007. In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date of Oct. 27, 2008 due to internal resource constraints. At that time, the FDA did not raise any issues with the data in the alogliptin NDA.
Alogliptin, which was discovered by Takeda's wholly owned subsidiary, Takeda San Diego, is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.
In the 2008 guidance, the FDA recommended that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular (CV) events as a heart attack.
In its correspondence with Takeda, the FDA also said that it does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency said it is open to discussions regarding the design of additional CV studies with alogliptin. They added that alogliptin's Prescription Drug User Fee Act (PDUFA) date of June 26, 2009 remains unchanged.
Takeda originally submitted its NDA for alogliptin to the FDA in December 2007. In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date of Oct. 27, 2008 due to internal resource constraints. At that time, the FDA did not raise any issues with the data in the alogliptin NDA.
Alogliptin, which was discovered by Takeda's wholly owned subsidiary, Takeda San Diego, is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.