FDA wants additional study of diabetes drug

By Bruce Japsen | Tribune staff reporter

3:50 PM CDT, June 27, 2009

In a blow to the diabetes treatment franchise of a Deerfield drug maker, the U.S. Food and Drug Administration has asked Takeda Pharmaceuticals North America Inc. to conduct an additional heart safety trial of its experimental drug alogliptin, the company said this afternoon.

It's unclear when the new trials would begin or when Takeda would attempt to re-submit the drug to the FDA for possible approval as a treatment for 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.

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.

A newer class of drugs that Takeda's alogliptin is a part of has been lucrative for one such product on the market. 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.

Takeda's Actos sales are $4 billion globally a year but the drug's patents begin to expire in the next two years, opening the product to competition from cheaper generics that will begin to erode the company's diabetes drug sales. Analysts have said Takeda was looking to alogliptin to fill the void of lost sales from Actos.

In March, Takeda said the FDA would apply new safety guidelines issued in December for evaluating heart risks in new therapies to treat Type 2 diabetes. Today, Takeda said the FDA issued the company a "complete response letter" on Friday, but the company did not elaborate on the document's contents other than to reiterate its statement in March that "FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in" the agency's new guidance on diabetes drugs.

Takeda issued a brief statement that did not provide specific plans for the future study of alogliptin. "Takeda will continue to promote key initiatives in order to realize sustained growth from a medium- to long-term perspective," said Yasuchika Hasegawa, president of Takeda Pharmaceutical Company Ltd, Japan's largest drug maker and parent of the Deerfield operation.

bjapsen@tribune.com