This morning Sanofi-Aventis (NYSE:SNY) announced that the Food and Drug Administration (FDA) has considered its October 26th, 2006 resubmission to be a complete, class 2 response to the FDA February 17th, 2006 action letter. A final decision on Acomplia® is expected in late April 2007.
This news comes on the heels of the company’s release of data from their SERENADE study at the International Diabetes Federation (IDF) World Diabetes Congress in Cape Town, South Africa this past Tuesday. SERENADE was a multi-center randomized, double-blinded, placebo-controlled study, parallel-group study comparing Acomplia 20 mg once daily to placebo in improving blood sugar control (as indicated by A1C in treatment-naïve type 2 diabetic patients not adequately controlled by diet alone for a period of six months.
It is clear from the design of this study that Sanofi is attempting to position Acomplia as front line therapy for the treatment of type 2 diabetes. Originally Acomplia primary indication was to promote weight loss but with the correlation between obesity and diabetes the company quickly realized its potential as treatment for type 2 diabetes. A market that is growing at double digit rates and has attracted the attention of nearly every major pharmaceutical company. While metformin continues to dominate this market a host of new drugs have come along as combination therapy is quickly becoming the standard for treating type 2 patients. Recently TZD’s such as Avandia from GlaxoSmithKline (NYSE:GSK) and Actos marketed by Lilly (NYSE:LLY) and made by Takeda, have come under attack due to concerns over their adverse event profile. Januvia from Merck (NYSE:MRK) is part of a new class of drugs called DPP-4’s. Although in clinical trials Januvia was not as effective as either Avandia or Actos, the results were comparable with a much better adverse event profile. Also in the field is Byetta an injectable GLP-1 from Amylin (NASDAQ:AMLN). Byetta has proven to be effective at glucose control with the added benefit of progressive weight loss.
Looking over the results from SERENADE it’s difficult to see a compelling reason for physicians to prescribe Acomplia should the drug receive approval, which by no means is a slam dunk. While the company did its best to dismiss the fact that nearly 10% of the study participants dropped out of the study, this fact alone should send up a red flag. The main concern surrounding Acomplia since its introduction has been the possibility of psychiatric disorders. In the study 17.4% of the patients taking Acomplia experienced some type of psychiatric event, which were defined as anxiety, depressed mood, insomnia, depression and initial insomnia. The reality is no one is quite sure what affect Acomplia has on the brain or put another way even the people at Sanofi aren’t quite sure how the drug works. Given that physicians have multiple alternatives and the questions surrounding Acomplia Diabetic Investor suspects if approved the drug would face an uphill battle.
With the avalanche of new data on existing and new drugs its becoming crystal clear that the type 2 medication market is beginning to look like the cholesterol market did a few years ago. The one big difference being in the type 2 diabetes market the regaining champion is a generic, metformin. Like Rocky Balboa who continues to fight into his 60’s taking punch after punch but remains champ, metformin first launched in 1958 continues to hold the title as the oral medication of choice for treating type 2 diabetes. Try as they might there is one thing pharmaceutical companies can’t change and that’s physicians have a high degree of confidence in metformin which is backed by nearly 50 years of patient experience with the drug. It will take more than a few jabs to knock out this champ.