Controversial obesity drug gets UK okay
Wed Jun 25, 3:23 AM ET
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)
