The highly anticipated diet drug Acomplia (rimonabant), still awaiting formal approval by the European Commission, may be available for purchase as early as July in Britain or Germany, according to developer Sanofi-Aventis.
Hanspeter Spek, executive vice president, pharmaceutical operations, Sanofi-Aventis, told financial analysts on May 5th that Sanofi is "very active in preparing for our first launches," which almost surely will take place in Europe and not the United States.
A committee of the European Medicines Agency (EMEA), the Committee for Medicinal Products for Human Use (CMPH), recommended approval of Acomplia as an aid to weight-loss on April 28th. More than 95 percent of CHMP recommendations lead to EMEA marketing authorizations in just over two months.
"We are confident to launch in the first market then in the period July to August, and those markets traditionally in Europe are the United Kingdom and Germany," Spek said.
While Spek declined to provide new information on Sanofi's efforts to get approval of Acomplia by U.S. Food and Drug Administration, which has held up action pending resolution of undisclosed issues, he also radiated optimism on prospects for an early introduction of the drug in the United States.
"We are still planning and continue to plan for our launch in the U.S. also in the second half of 2006," Spek declared.
As for the outstanding issues that need to be resolved with the FDA, Spek said: "I said earlier we are in a permanent dialogue with the agency and I have nothing to add to this. On Acomplia, I think we can say absolutely nothing else."
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