Wednesday, April 1, 2009

The FDA Does Diabetes

So far, patients can breathe a sigh of relief.

The U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee met today, and will continue its discussions tomorrow, on two important diabetes drugs which are under review at the FDA.

The first drug, reviewed today, was Bristol-Myers Squibb’s saxagliptin, an oral pill which treats diabetes in a similar way to Merck’s Januvia and Novartis’ Galvus. (Galvus has been in limbo at the FDA for years, for no discernible reason.) Tomorrow, the FDA panel will review Novo Nordisk’s Victoza, an injectable drug similar to Byetta (a marketed drug from Eli Lilly and Amylin Pharmaceuticals).

The FDA had been somewhat concerned about a slight increase in cardiovascular side effects of saxagliptin relative to placebo in Bristol’s late-stage clinical trials, but the panel voted 10-2 that the clinical data provided appropriate evidence of saxagliptin’s safety profile. The panel did recommend additional clinical trials for cardiovascular safety after the drug makes it to market, but such recommendations are not so easy to implement.

Tomorrow, on April 2, the panel takes up Novo’s Victoza (liraglutide). The FDA has raised concerns about major adverse cardiac events and thyroid tumors. Novo will probably have to do an additional post-marketing trial. We will have a more complete review of the Advisory Committee meeting at that time.

Investors in Amylin and Lilly cheered when the FDA’s briefing documents on liraglutide contained no questions regarding inflammation of the pancreas, a side effect associated with their drug Byetta.

More on this tomorrow…

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