European regulators have granted marketing authorization for Sanofi-Aventis’ Acomplia (rimonabant) for the treatment of obese or overweight patients.
Acomplia will be made available as a 20-mg tablet with the first launch taking place in the UK in July. Subsequent launches will take place in Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.
Sanofi-Aventis hopes to receive FDA approval for Acomplia to treat weight loss before the end of 2006.
In February, the FDA declined approving Acomplia for smoking cessation. The agency issued Sanofi-Aventis an “approvable” letter outlining what it must do to win US approval of Acomplia to treat weight loss. Neither Sanofi-Aventis nor the FDA have disclosed the conditions of the letter.
Earlier in the year, Sanofi-Aventis CEO Jean-Francois Dehecq said he expects Acomplia sales to reach as high as $3 billion.
Some analysts’ estimates put sales of Acomplia at $4 billion annually by 2010.