Alogliptin's Application Under Scrutiny

PPD Inc. said Friday it is no longer forecasting that it will receive a $25 million payment this year connected with a new drug application for the diabetes drug alogliptin.

The drug's owner, Takeda Pharmaceutical Co., announced Friday that alogliptin's application will now be subject to scrutiny under the U.S. Food and Drug Administration's guidance on cardiovascular risk in new treatments for Type 2 diabetes.

Takeda said it had filed the application with the FDA before the cardiovascular guidance was issued in December.

Takeda also said the FDA believes that alogliptin clinical data is insufficient to meet certain requirements under the guidance.

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