FDA Rejects Savient’s Gout Drug
UPDATE: The FDA in a surprise decision declined to approve, Krystexxa, a gout drug manufactured by Savient Pharmaceuticals of East Brunswick, NJ.
The FDA declined the drug’s approval despite receiving a 14-1 recommendation for approval by its advisory committee in June. Generally, the FDA follows the recommendations of its advisory committees.
Savient plans to resubmit its application for approval Krystexxa early next year.
The FDA’s decision seems to be based on the drugs manufacturing process and not based on its effectiveness, according Savient’s press release.
The agency also concluded that a proposed change in the manufacturing process might make the drug sold to consumers different from the experimental drug tested in the clinical trial.
In addition, the FDA also said that Savient would need to have a program to monitor and reduce the side effects of the drug, particularly allergic reactions and cardiovascular problems.
Krystexxa was developed to treat gout, which is a painful form of arthritis. Gout is increasing because of richer diets, obesity and the aging of society.
The FDA typically does not discuss such regulatory decisions.
For more information please see: