Savient Pharmaceuticals Inc. said Tuesday that the U.S. Food and Drug Administration has approved its drug for treating adult patients with a type of chronic gout that doesn't respond well to conventional therapy.
The drug, dubbed Krystexxa, is made to treat adult gout patients who have failed to normalize serum uric acid. As a result, these patients' symptoms can't be alleviated with xanthine oxidase inhibitors at the maximum dose, the company said.
Clinical data show many patients treated with Krystexxa can experience significant improvement reversing the course of the debilitating disease within six months, said Paul Hamelin, Savient's president.
Savient expects the drug will be available by prescription in the U.S. later this year.
The FDA granted Krystexxa "orphan drug" designation in 2001. Savient expects that will provide the drug seven years of market exclusivity.
The composition, manufacturing and methods of use also are the subject of a broad portfolio of patents and applications that Savient expects will provide protection for the company into 2026.
Savient shares rose $3.04, or 20.6 percent, to $17.80 in aftermarket trading after slipping 6 cents to $14.76 during the regular session.