Not Just Diabetes: FDA Eyes Expanded CV Data for a Range of Drug Categories

More detail is emerging about what the FDA wants to see from drugmakers in terms of managing heart and cardiovascular side effects in new drug applications. BNET reported Nov. 17 that the FDA was in the process of sending letters to companies developing new diabetes drugs that said the feds will want to see more data on CV risks before approving new drugs in that category.

The companies on the FDA's mailing list, according to TheStreet.com, are: Amylin Pharmaceuticals, Vivus, Incyte Pharmaceuticals, and Roche, which all have diabetes drugs in mid- to late-stage clinical trials. Also expected to receive the notes are Novo Nordisk ( which is developing liraglutide), Takeda, AstraZeneca and Bristol-Myers Squibb.* Says Morgan Stanley analyst Steve Harr:

The companies under review have the greatest uncertainty, and outcomes will impact these companies and competitors ... An FDA mandate for cardiovascular screening trials prior to approval for all novel diabetes drugs will slow development and increase costs (potentially making it uneconomical for some and pushing incremental capital in other directions).

Dr. John Jenkins, director of the FDA's Office of New Drugs, told Reuters recently that the FDA was eyeing an expansion of its requirements for CV side effect monitoring:

There have been a string of products or classes of products where we're now seeing concerns about increasing the risk of cardiovascular events ... We are thinking about what the implications of these new data and these new findings are for all chronically used drugs ... It's changing how we look at how much data you need to get a drug approved ... [The agency] might look at more requirements for large studies after approval ... patients with rheumatoid arthritis have an increased risk of cardiovascular disease, so we have to start thinking about those issues.