Savient Pharmaceuticals has won FDA approval for Kyrstexxa (pegloticase), a closely-watched drug for chronic gout in adult patients refractory to conventional therapy. Gout, which affects more than 5 million Americans, is caused by the buildup of uric acid in the blood and soft tissues which can cause pain, swelling and stiffness. Last year the agency had rejected Savient's request for an approval of the drug after citing "deficiencies with the chemistry, manufacturing and controls" in its BLA. But the developer returned to its original manufacturing process and was able to gain approval of Kyrstexxa without any additional testing.
Savient expects the drug to be available in the U.S. later this year, saying that it's in advanced preparations for the U.S. launch of Kyrstexxa. In May the company revealed that it would be one the market if the drug were approved, and Savient noted in today's release that the exact date of the drug's launch will be determined in part to Savient's effort to find a buyer. According to TheStreet, analysts expect Kyrstexxa to bring in about $230 million annually.
It's been a good couple of years for the gout market. In early 2009 Takeda won approval of Uloric, the first new gout drug to hit the market in 40 years.