29 April, 2006  21:24 GMT
The
European Medicines Agency has recommended an innovative new weight-loss pill for approval, the drug's maker, Sanofi-Aventis SA, announced Friday. Sanofi shares rose 2.7 percent to
The US
Food and Drug Administration issued an "approvable letter" for Acomplia in February, a step toward its approval for weight control.
The EMEA committee, whose recommendations are usually followed by European Union regulators within three months, recommended approval of the drug -- also known by its chemical name, rimonabant -- for some overweight or obese patients.
But Sanofi failed to win the agency's approval to make Acomplia available as an anti-smoking drug. The EU committee "has not adopted a positive opinion for Acomplia in smoking cessation," the company's statement said, without giving further details.
The FDA also declined to recommend Acomplia's approval as an anti-cigarette addiction treatment in February, and said it needed further information before approving it as a weight-loss tool.
Cosmetic Use Not Recommended
Merrill Lynch raised its 2010 EU revenue forecast for the drug by 50 percent to |