WASHINGTON - Savient Pharmaceuticals Inc., a money-losing biotechnology company whose only drug lost patent protection in 2006, has failed to win US approval to sell a new gout treatment because regulators need more information.
The Food and Drug Administration issued a so-called complete-response letter, raising issues including the manufacturing process for the medicine, Krystexxa, and guidelines on evaluating its safety and efficacy, the company said.
While 3 million Americans have gout, this drug was developed for the tens of thousands whose disease does not respond to conventional therapy.
Gout is a form of arthritis in which deposits of uric acid build up around joints, causing pain, swelling, and stiffness. It was historically known as a disease of kings because obesity, alcohol, and protein-rich diets increase the risks.
Krystexxa is derived from an animal hormone that rids the body of uric acid by converting it into a form that is easily excreted.
“We are committed to work diligently to address these issues with a goal of obtaining final approval,’’ Savient president Paul Hamelin said in a prepared statement.
The company expects to complete its resubmission in early 2010, Hamelin said. East Brunswick, N.J.-based Savient said it plans to request a meeting with the FDA to discuss and clarify the issues in the regulator’s response.
Savient must include an update of safety data from all ongoing studies in its refiling, the company said in the statement. An inspection report of the drug-substance manufacturing plant is also required, it said.
An FDA advisory panel voted 14 to 1 in favor of approval of Krystexxa, also known as pegloticase, on June 16.