Amylin's Symlin Cleared by FDA
Updated from 5:17 p.m. EST
Amylin Pharmaceuticals
(AMLN)
said Wednesday that the Food and Drug Administration had approved the company's first product, Symlin, an injectable drug to be used with insulin in treating diabetes.
The product will reach the market in 90 days.
The FDA's approval, announced after markets had closed, represents the conclusion of a more than four-year regulatory review process for the drug. San Diego-based Amylin submitted its original application in December 2000, and the FDA asked for additional clinical information in October 2001 and again in December 2003.
"The approval of Symlin ... is a major milestone for Amylin Pharmaceuticals," said Ginger L. Graham, the company's president and CEO. "It is the result of 18 years of research in diabetes."
The company's stock was halted before the announcement, but in after-hours trading, it jumped $4.47, or 22.9%, to $24.
Symlin is prescribed for use at mealtime in patients with type 2 or type 1 diabetes who have failed to achieve blood sugar levels despite their having taken insulin. The company said Symlin helps patients achieve lower blood sugar levels after meals, "leading to less fluctuation during the day, and better long-term glucose control compared to patients taking insulin alone."
Amylin said its clinical tests showed that patients taking the drug used less mealtime insulin and lost more weight than patients taking insulin alone.