Diet drug Acomplia (rimonabant), stalled at the U.S. Food and Drug Administration for more than a year, now will not be acted on at least until the end of July, Sanofi-Aventis announced on February 12th.
The French pharmaceutical company said that in an effort to approve chances that Acomplia will be approved for sale in the United States, it has submitted new data from its SERENADE study to the FDA showing that the drug also improves blood sugar control in patients with Type 2 diabetes.
No reason for the new delay was given by Sanofi or the FDA, but few observers believe the agency will act on Acomplia until its Endocrinologic and Metabolic Drugs Advisory Committee weighs in on the issue of the drug's side-effects.
The advisory committee's next meeting is tentatively scheduled for June 13 and 14th.
Sanofi has long refused to provide any information about what sort of data the FDA has been seeking, though many analysts have speculated that it involves concerns about Acomplia's side effects, which include depression.
Clinical trials had a relatively high patient dropout rate due to such side effects as dizziness, nausea, anxiety and depressed feelings.