obesity drug, still in regulatory limbo in the U.S., has been approved by the European Union.
The French drug giant said Wednesday that the EU had endorsed Acomplia as an add-on treatment to diet and exercise for obese patients or for overweight patients who have certain risk factors such as diabetes.
The once-a-day pill first will become available in the U.K. next month, followed by Denmark, Ireland, Germany, Finland and Norway during the second half of the year. The announcement sent the company's stock up 70 cents, or 1.5%, to $46.31.
However, the big question remains regarding when Acomplia will be available in the U.S., which would be the biggest market and where Sanofi-Aventis has applied to sell it as an obesity treatment and a stop-smoking drug.
In February, the Food and Drug Administration granted tentative approval for Acomplia for weight management, but Sanofi-Aventis officials haven't described what they need to do to gain full clearance or predicted a precise timetable for selling the drug. The company has said the FDA isn't seeking more clinical trials, and it has indicated that it expects to launch the drug in the U.S.
during the second half of the year.
However, to get Acomplia approved to help smokers quit, Sanofi-Aventis will have to conduct another clinical study. At the same time it gave tentative approval for the weight-management indication, the FDA rejected the smoking-cessation application. The company hasn't commented on whether it will pursue the matter.
"The approval of Acomplia in the European Union is important news for obese and overweight patients," Jean-François Dehecq, chairman and CEO of Sanofi-Aventis, said in a prepared statement.
The most common side effects that caused clinical-trial patients to stop taking the drug were nausea, mood alteration with depressive disorders, anxiety and dizziness, the company said. In placebo-controlled tests, the drop-out rate due to side effects was 15.7%.
Sanofi-Aventis added that the drug shouldn't be given to people with liver or kidney problems or to people with "uncontrolled serious psychiatric illnesses" such as major depression.