Controversial obesity drug gets UK okay
LONDON (Reuters) - Sanofi-Aventis won a final green light for its obesity drug Acomplia from Britain's cost-effectiveness watchdog NICE on Wednesday, clearing the way for doctors to prescribe it on the state health service.
The move was expected following a positive appraisal from the National Institute for Health and Clinical Excellence (NICE) in March.
It marks a small positive for the French drugmaker's once much-hyped medicine, which has failed to live up to early expectations.
NICE's final guidance recommends using Acomplia, or rimonabant, as an addition to diet and exercise for obese or overweight adults who don't respond to or are intolerant of two other weight-loss drugs, orlistat and sibutramine.
But NICE cautioned that treatment should not continue beyond six months unless patients lost at least 5 percent of their initial body weight and there should, in any event, be a formal clinical assessment after two years.
The UK decision contrasts with Germany where Acomplia is not reimbursed by health insurers because it is deemed simply to improve lifestyle.
Acomplia was once touted as a multibillion-dollar seller, but hopes for the product dimmed last year when a U.S. expert panel recommended against its approval in the world's biggest market, after it was linked to rare cases of suicidal thoughts.
Sanofi said in October it expected only limited sales of the drug in the next few years, until new clinical trial results testing it in diabetes are ready for submission to regulators in 2009.
Worldwide sales of the drug were a meager 79 million euros ($122.9 million) last year.
Roche makes the older weight-loss drug orlistat under the brand name Xenical, while sibutramine is marketed by Abbott Laboratories under the brand names Meridia or Reductil.
(Reporting by Ben Hirschler; Editing by David Cowell)
