Savient Doesn't Expect Need for New Krestexxa Trials
Wed, 09/16/2009 - 4:44am
EAST BRUNSWICK, N.J. (AP) — Savient Pharmaceuticals Inc. said Wednesday it does not think it will have to run new trials of its chronic gout drug candidate Krystexxa, and believes it can complete a new regulatory submission for Krystexxa in early 2010. The FDA declined to approve Krystexxa in August because Savient changed the way the drug was manufactured, among other issues. Based on a meeting with the FDA Monday, Savient said the FDA does not expect to require another late stage test, provided the drug is essentially the same regardless of the manufacturing process. The FDA also told Savient what it will need to correct problems at a manufacturing facility in Israel, and said it will accept a safety update on Krystexxa, Savient said. Gout is a painful type of arthritis caused by excess uric acid crystallizing and building up around joints and tendons, which causes inflammation. Krystexxa is intended for patients whose other gout treatments have failed. Shares of Savient advanced $1.12, or 7 percent, to $17 in premarket activity. The stock has ranged from $2.80 to $21.25 over the past year.