The Food and Drug Administration will take three months longer than it expected to decide whether to approve Auxilium Pharmaceuticals Inc.'s Xiaflex drug for more than its original use.
Xiaflex is approved in the United States and Europe, among other places, to treat a rare condition called Dupuytren's contracture, which causes the tendons of the hand to thicken and shorten, making the fingers curve inward. The company also is asking the FDA to approve the drug to treat Peyronie's disease, which causes abnormal curvature of the penis.
The FDA says that revisions that Auxilium submitted to the drug's proposed label represent a "major amendment," so they've pushed back the action date to Dec. 6 from Sept. 6. The Chesterbrook, Pa., company said Wednesday that it is disappointed by any delay in approval but noted that the FDA is not requiring additional clinical studies be conducted, which would have delayed the process much longer.
The company's shares climbed 5.5 percent, or 96 cents, to $18.47 late Wednesday morning, while broader trading indexes rose slightly. The stock fell from a 52-week high of $25.54 last fall to bottom at $13.87 this spring, but has slowly been regaining ground over the past few months.