The Panel Has Spoken

The Panel Has Spoken

Yesterday a Food and Drug Administration (FDA) advisory panel recommended the FDA require that companies conduct long-term studies in order to rule out cardiovascular risks for new diabetes drugs. The panel did not recommend that new drugs show a cardiovascular benefit. According to panel member and physician Jessica W. Henderson “Showing cardiovascular benefit would be nice to know. But ruling out cardiovascular risk is a need-to-know.” Although the FDA is not required to follow the panel’s recommendation they normal do so.

Diabetic Investor is not surprised by the panel’s recommendation and sees this as a positive development. Based on the reaction in the market investors feel differently. Shares of Amylin (NASDAQ:AMLN) and Novo Nordisk (NYSE:NVO) are both down on the news, Novo off nearly 4%. Novo’s GLP-1 Liraglutide is currently awaiting FDA approval while Amylin is getting set to submit their long-acting once-a-week version of Byetta to the FDA later this year or early 2009. Apparently investors believe that this new guidance will slow down the approval process for these two important drugs.

In actuality investors should be rejoicing over this news as the guidelines clearly favor GLP-1 therapy. According to Amylin “In addition to weight loss, patients treated with exenatide once weekly experienced the following effects on several cardiovascular risk factors, including total cholesterol (total cholesterol -11.9+/-2.3 mg/dL from baseline 173 mg/dL; LDL -4.9+/-2.0 mg/dL from baseline 91.6 mg/dL; HDL -0.9+/-0.6 mg/dL from baseline 43.9 mg/dL) and triglycerides (15 percent improvement of mean ratio of week-30 to baseline from a baseline of 166.0 mg/dL).” (These results came from the DURATION-1 trial.) Both Amylin and Novo have reported that patients on their respective GLP-1’s see improvements in blood pressure as well.

With this new emphasis on the cardiovascular profile of a drug, GLP-1 therapy gains another selling point. It’s well known that weight loss leads to several improvements in cardiovascular risk factors. It’s also true that at best alternate therapy options such as Januvia are weight neutral. Add it all up and the market for GLP-1 therapy keeps getting better and better. Simple dosing, strong glucose lowering and weight loss make a powerful combination. Physicians will be hard pressed to find this combination of benefits anywhere else.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile