It was plastered all over the news earlier this week. The committee of advisors to the U.S. Food and Drug Administration voted 22-1 to keep GlaxoSmithKline's Avandia on the market. They also voted 20-3 the evidence reveals Avandia increases risk of heart attack. Comforting, isn't it? Avandia, used to treat type 2 diabetes, has been under attack for cardiovascular risks since a late May study showed a 43 percent higher risk of heart attack.
Okay, so Avandia will likely get a black box warning from the FDA, its sternest alert to doctors. Pascale Boyer Barresi, an analyst at Bordier & Cie in Geneva stated the black box is likely and Avandia sales will probably not recover to previous levels. They might gain 10 to 15 percent, but doctors who switched their patients will not switch back. No doubt a big factor in Avandia sales will be new prescriptions. In the U.S. they fell 45 percent after the May report, and I'm sure Glaxo investors are wondering if Avandia has potential to grow market share. This drug drew $3.3 billion in 2006 sales. Stuart Weiss, an endocrinologist with New York University Medical Center, stated until new data comes in, it will be difficult to start new patients on the drug. This is feedback from an endo, don't forget endocrinologists and cardiologists tended to reside in opposing camps when the Avandia news broke in May. Endos were more skeptical of the May study -- cardiologists gave it more weight.
Once the FDA finally weighs in, I suspect Glaxo's public relations and sales teams will launch one giant persuasion campaign. New type 2s are being diagnosed daily, and Glaxo wants Avandia up and front for consideration. Will doctors and patients follow their advice? The FDA's committee of advisors have left the room, now let's see what the FDA decides on labeling. Read more in Bloomberg.