WASHINGTON — A panel of arthritis experts say a gout drug made by Savient Pharmaceuticals should be approved, despite some reports of heart problems in patients tested with the drug.
In heavy aftermarket trading, Savient shares jumped $2.62, or 28.3 percent, to $11.89. The shares had finished the regular session at $9.27.
The Food and Drug Administration’s outside panel on Tuesday voted 14-1 that the drug Krystexxa appears safe and effective and should be approved, according to an agency spokeswoman.
Before the meeting, FDA drug reviewers noted higher rates of heart problems among patients who took the drug, versus those taking placebo. However, panelists said the data did not definitively prove there was a risk.
A final decision on Savient’s drug is expected by the end of July.
East Brunswick, N.J.-based Savient has asked the FDA to approve Krystexxa for patients with gout who already have tried other drugs. Gout is a painful condition that causes swelling around the joints due to a buildup of uric acid in the body.
Source: http://www.miamiherald.com/business/nation/story/1100171.html