'Miracle' obesity pill looks less miraculous
When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz.
Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia, as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid.
"That is amazing. People are going to want this drug today, I'm sure," effused an anchor on ABC's "Good Morning America."
Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia - including depression and anxiety - are likely giving the FDA particular cause for concern, analysts and doctors say.
Sanofi announced this week that the FDA has scheduled a meeting of its outside advisers on June 13 to review Acomplia's safety and efficacy. That could be a precursor to a final decision.
Acomplia faces trouble in Europe, too. European regulators approved it for sale last summer, but Germany's state-financed health-care system thinks the drug has few real medical benefits and is refusing to pay for it. Other countries, including France, are covering the drug only for limited groups such as people with diabetes.
Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia, as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid.
"That is amazing. People are going to want this drug today, I'm sure," effused an anchor on ABC's "Good Morning America."
Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia - including depression and anxiety - are likely giving the FDA particular cause for concern, analysts and doctors say.
Sanofi announced this week that the FDA has scheduled a meeting of its outside advisers on June 13 to review Acomplia's safety and efficacy. That could be a precursor to a final decision.
Acomplia faces trouble in Europe, too. European regulators approved it for sale last summer, but Germany's state-financed health-care system thinks the drug has few real medical benefits and is refusing to pay for it. Other countries, including France, are covering the drug only for limited groups such as people with diabetes.
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