Diabetes-Drug Makers Face FDA Hurdle

Concern over reports that link diabetes drugs to heart trouble is compelling U.S. drug regulators to ask diabetes-drug makers for more safety data. These requests for additional data could delay new product approvals by years and add millions of dollars to development and post-market commitment costs.

The U.S. Food and Drug Administration is reportedly sending letters to all companies with diabetes drugs in development, informing them that the agency will now require safety data prior to approval that measures a drug's cardiovascular risk.

Companies reportedly receiving the FDA letters include Amylin Pharmaceuticals (AMLN Quote), Vivus (VVUS Quote), Incyte Pharmaceuticals (INCY Quote) and Roche, according to sources familiar with the letters. All have diabetes drugs in mid- to late-stage clinical trials.

"It appears companies with drugs at the FDA -- Novo Nordisk (NVO Quote)(liraglutide), Takeda (alogliptin) and AstraZeneca (AZN Quote)/Bristol-Myers Squibb (BMY Quote) (saxagliptin) -- have not yet received a letter, although discussions with industry participants lead us to believe they are coming," wrote Morgan Stanley biotech analyst Steve Harr in a note to clients on Friday. "The companies under review have the greatest uncertainty, and outcomes will impact these companies and competitors." ...