U.S Health Panel to Review Sanofi's Acomplia in June
26 March, 2007
Sanofi-Aventis said on Monday a U.S. panel of health experts would review its anti-obesity pill Acomplia in June, a move which analysts said caused new concerns over whether it would win U.S. marketing approval by the Food and Drug Administration.
Shares in the French drugmaker lost as much as 2 percent and were off 1.5 percent at 64.39 euros by 1454 GMT, while the DJ Stoxx European health sector index fell 0.5 percent.
"It (the panel meeting) indicates there are more question marks or concerns that need to be ironed out in a broader forum. It's a way for the FDA to hedge itself," Karl Heinz Koch, analyst at Vontobel said.
A Sanofi spokeswoman said that the Endocrinologic and Metabolic Drugs Advisory Committee meeting on June 13, to discuss the safety and efficacy of Acomplia, would not "endanger" the FDA's expected marketing decision on July 26.
Some analysts said it was hard to assess what the meeting would mean for the drug's possible approval but it could improve the chances of it winning a diabetes label.
Clinical trials have shown Acomplia cuts weight and waist circumference, improves good cholesterol and blood sugar levels in type 2 diabetics, and reduces fat levels in the blood.
The studies have also shown a fairly high patient dropout rate due to side-effects like nausea, anxiety and depression.
"The drug has shown efficacy but is that large enough to warrant the unexplained safety issues -- that will require the input of more specialists," Koch said.
Acomplia is being prescribed in a number of European and Latin American countries but the U.S. health regulator several times delayed its marketing decision on the drug that Sanofi had had hoped to launch in the United States about a year ago.
In the European Union Acomplia won approval as a complementary to diet and exercise to treat obese or overweight patients who suffer from type 2 diabetes and abnormal levels of fat in the blood. For now the drug is being reimbursed in six out of 10 EU countries where it is being prescribed.
"This doesn't come as a huge surprise," a London-based analyst said. "It's difficult to interpret what the meeting could entail -- it adds another layer of risk. They might come down strongly but on the other hand without the meeting it might not get a diabetes label."
Acomplia is a new type of drug which works by blocking the so-called cannabinoid type 1 receptor in the brain to diminish cravings for food.
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