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Sanofi-Aventis SA faces new challenges
on its obesity drug Acomplia, after alarming studies were published on Friday
in two scientific magazines: The Lancet and the British Medical Journal. The French
drugmaker’s problems follow the recent launch in the United States of a lawsuit against
the company because of its allegedly making misleading statements about
Acomplia.
Sanofi-Aventis represents the
third pharmaceutical company of the world, but in June it had to pull its application
for marketing approval of the obesity drug in the United States, because the Food and Drug Administration rejected the drug over concerns of psychiatric
side effects. Since then, the French drugmaker’s stock has fallen 17 percent,
while the company has been planning to resubmit the application to the FDA once
it gathers new information from ongoing clinical trials.
But the studies published on
Friday in the two scientific magazines came before Sanofi-Aventis’s own test
results and confirmed the Food and Drug Administration’s concerns on Acomplia’s
severe psychiatric side effects. According to the studies, not only does the
obesity drug increase the risk of depressed mood disorders and anxiety, but it is
also almost ineffective against obesity, as people lose less than 5 percent of
their total body weight.
Sanofi-Aventis’ spokesman stated
that the company “believes that the meta-analyses do not reveal new objective
data given what is already known by the medical communities and the Health
authorities." He also said that only the patients that already suffer from
depression are affected by what the two studies called Acomplia’s side effects.
Acomplia, which is known to American consumers
as Zimulti, is marketed in 21 countries outside the Untied States and
reached important sales in the recent period.
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