It’s not easy for diet drugs to get approval from the FDA. Orexigen Therapeutics, Vivus and Arena Pharmaceuticals, all had obesity drugs shot down by the government agency. You may have to add Amylin Pharmaceuticals to the list.
The company has halted testing on its combination therapy pramlintide/metreleptin in its phase two study. In a recent press release, Amylin says that it stopped the study voluntarily “to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.”
While the company says that they will work with the FDA and researchers to “to determine the best path forward,” I wouldn’t hold your breath on approval given the track record of obesity-related drugs being approved.
Amylin is also having trouble with the experimental drug Bydureon meant for diabetics. It was found to be less effective in a study compared with Novo Nordisk’s Victoza, which is already approved.
March 23rd, 2011