Details from a stopped study with Sanofi-Aventis' FDA-challenged atrial fibrillation drug Multaq - which the company plans to resubmit for approval in the third quarter - were reported June 19 in The New England Journal of Medicine.

The full results come from the study called ANDROMEDA, which stands for "Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease."

Data show 25 of about 310 people who took Multaq died after two months, versus 12 deaths among 317 of those on placebo. Death rates reached 8.1 percent in the Multaq group, compared to 3.8 percent in placebo.

Sanofi quit the study, which enrolled patients with congestive heart failure and ventricular dysfunction, in early 2003, after a safety panel pointed to death risk.

In May, Paris-based Sanofi reported that one-year follow-up data from a different study, called ATHENA, met the primary endpoint in AF (¹ Also see "Sanofi-Aventis Heart Drug Multaq Back To FDA In Third Quarter" - Pink Sheet, 15 May, 2008.).

ATHENA, with a primary endpoint of time to first heart-related hospitalization or death from any cause, achieved a 24 percent decrease in that risk category - and even proved Multaq effective in patients with congestive heart failure.

FDA declared Multaq "not approvable" in 2006 (² Also see "Sanofi Dronedarone Re-Filing Anticipated In 2008 After FDA “Non Approvable” Letter" - Pink Sheet, 31 August, 2006.).

Also in AF, Astellas and Vancouver, B.C.-based Cardiome's injectable Kynapid (vernakalant) is still under FDA review after an advisory panel gave it the thumbs-up.

Positive Kynapid trial data were published this spring (³ Also see "Astellas/Cardiome Reports Positive Kynapid Phase III Study" - Pink Sheet, 26 March, 2008.). Around the same time, encouraging results from a Phase IIb trial with an oral version were disclosed.

- Randall Osborne (r.osborne@elsevier.com)

ANDROMEDA Strain: Full Data Published From Multaq Trial

More from Archive

More from Pink Sheet