Those of you who read our Special Report on Diet Drugs got a heads up on both the extension of the QNEXA PDUFA Date and the easy time that LORQESS had with the FDA Advisory Committee last week. But now it’s crunch time and the folks at Vivus and Arena Pharmaceuticals are supplementing their diets with fingernail sandwiches. Arena has the shorter wait at this time, June 27, 2012 is still their PDUFA Date for LORQESS. By virtue of the extension, Vivus has to wait until July 26, 2012.
Neither the FDA nor the Advisory Committees have questioned the efficacy of either drug. Neither set of reviewers have tried to say one is more efficacious than the other. I agree and would call them equally efficacious.
Both drugs have reported or perceived cardiovascular side effects. According to the Advisory Committee earlier this year, such drugs should be required to have cardiovascular studies performed before approval. However, both drugs were submitted for approval and under review when the recommendation, and it is only a recommendation, by the Advisory Committee was made. That being said, the FDA has a certain degree of leeway in forcing this requirement as an approval requirement. In my opinion, the FDA will give both companies a break and allow the required study to be done as a condition of approval. It will be the most closely watched event since the OJ trial. One might think that QNEXA has the leg up on this because they went to the Advisory Committee first, but in this case, one would be wrong. Both companies got the information at the same time – from listening to the Advisory Committee live and in person. Who has the edge on having the protocol in final form? I don’t know and neither does anyone else except maybe the FDA and I heard they ain’t talking.
FDA doesn’t have to talk about the cardiovascular protocol race because the race isn’t about the cardiovascular side effects, its about the teratogenicity risk. FDA is breathing a sigh of relief with the data from Arena and the positive vote from the Advisory Committee for LORQESS. The pressure is off – they have a viable diet drug alternative to QNEXA to satisfy those screaming for a new drug. And they have an alternative that is not a teratogen. Even if LORQESS gets an extension of the PDUFA Date from FDA to tidy up their cardiovascular study protocol, they will still be ahead of Vivus who has a somewhat longer struggle with the teratogencity issue.