Another Diabetes DDP-IV Inhibitor Drug Put on Hold by FDA

The FDA will take longer to review Alogliptin, an experimental diabetes pill developed by Takeda, delaying a potential blockbuster billion-dollar seller from reaching the market.

Potentially the next DPP-Inhibitor to make it into the American market will be Galvus(R) (vildagliptin).  Galvus has been approved overseas, yet it may also get delayed by the FDA. 

Takeda Pharmaceuticals North America Inc., said the FDA will apply new safety guidelines to its alogliptin drug, which will need additional clinical data in order to satisfy the agency’s review of the product before it can be sold as a treatment for diabetes. In December, the FDA issued new guidance for evaluating heart risks in new therapies to treat Type 2 diabetes, the most common form of diabetes in which the body does not produce enough insulin or ineffectively uses insulin. People with Type 1 diabetes produce virtually no insulin of their own.

It is unclear when the FDA might consider Alogliptin for possible approval but the agency doesn’t believe there is currently enough data to meet certain statistical requirements in the new guidance.

The FDA has intensified scrutiny of diabetes drugs in the wake of studies two years ago that showed an increased risk of heart attacks for patients taking Avandia, a once popular diabetes pill. Avandia and another Takeda product already on the market known as Actos are in a class of drugs known as thiazolidinediones, or TZDs.

Alogliptin is part of a new class of diabetes medicines known as DPP-4 inhibitors that are gaining in popularity. A leading brand in that class already on the market is Januvia, which generated $1.4 billion in worldwide sales last year for New Jersey drug giant Merck & Co.

A Takeda spokesman said the company would not comment on whether it plans to conduct additional studies.