SANOFI-Aventis has called a halt
to a new clinical trial of its heart
drug Multaq (dronedarone), after
an independent safety monitor
reported a “significant increase in
cardiovascular events” in the trial
group taking the drug.
The company had hoped the trial
would lead to an expansion of the
drug’s approval to treat patients
with permanent atrial fibrillation (AF).
Multaq is approved in the EU and
US for the treatment of nonpermanent
AF.
“We are notifying regulatory
authorities in all countries where
the product is approved or under
review on this matter,” said Sanofi’s
CMO Jean-Pierre Lehner.
“We remain committed to Multaq
as an essential treatment option for
non-permanent AF patients,” he
added.The above article was sent to subscribers in Pharmacy Daily's issue from 11 Jul 11 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 11 Jul 11
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