Strike this one up on the winners side of the FDA crap shoot board! Savient’s gout drug, Krystexxa; which was denied last year, has been approved by the FDA this evening. SVNT’s shares are up nearly 3 points or 21% in AH trading.
(Reuters writes) The U.S. Food and Drug Administration approved the use of Savient Pharmaceuticals Inc’s (SVNT.O) gout drug in adults who do not respond to other treatments or cannot take alternatives for various reasons.
Gout, a painful type of arthritis in which a build up of uric acid causes swollen joints, affects about 5 million Americans
The FDA said the drug Krystexxa, which was denied approval last year, is being approved with a risk evaluation and mitigation strategy (REMS).
The REMS program consists of a plan for health care providers and a medication guide for patients to communicate the risk of severe infusion and allergic reactions.