In February this year Orexigen was asked by the FDA (Food and Drug Administration) to carry out a sizable trial to evaluate the potential cardiovascular risks involved with taking its weight loss drug candidate, Contrave.
Orexigen recently asked the FDA if Contrave could be approved for patients with low cardiovascular risk. The FDA decided that they wanted to see the results of a pre-approval cardiovascular outcomes trial and that Orexigen’s proposal did not meet their objectives - much to the irritation of Orexigen, which feels that the amount of information requested is unnecessary and also difficult to complile. Even if the pharmaceutical company goes ahead with the trial, the potential agreement reached may be scrapped shortly thereafter considering that the FDA’s DMEP (Division of Metabolic and Endocrinologic Products) has decided to hold an advisory committee meeting next year to lay down ground rules for cardiovascular assessment relating to pre-approval obesity treatments.
The company has stalled further development of Contrave in the USA until they are given a clear path to regulatory approval. Orexigen has stated that it intends to accelerate its programme to get Contrave licensed in other territories and we believe that will include the EU so this could be good news for obese patients in Europe.