File this under sticking point. The agency wants Amylin Pharmaceuticals to run more studies of its Type 2 diabetes drug, which was approved two months ago as a stand-alone treatment, due to safety concerns over pancreatitis, according to an investor note issued yesterday by Citigroup analyst Yaron Werber.
At the time of the Oct. 30 approval, Amylin indicated prescribing info would warn about pancreatitis in patients with severe kidney disease. You may recall the twice-daily injectable drug was linked to six deaths last year (see here), which hurt sales. However, the Amylin statement didn't mention additional studies.
Werber wrote that he obtained a copy of the FDA’s approval letter (here it is) and the agency considers post-marketing reports of acute pancreatitis, acute renal failure and thyroid neoplasm to be new safety info. Amylin and Lilly, its Byetta marketing partner, issued a statement saying most of the studies are already under way and have not shown any increased risk of acute pancreatitis. Not surprisingly, Werber's note caused Amylin stock to drop; shares fell nearly 10 percent yesterday.