Savient Pharmaceuticals Inc. (SVNT), a money-losing biotechnology company whose only drug lost patent protection in 2006, failed to win U.S. approval to sell a new gout treatment because the regulator required more information.
The Food and Drug Administration issued a so-called complete-response letter raising issues including the manufacturing process of the medicine, Krystexxa, and guidelines on evaluating the drug’s safety and efficacy, the company said in a statement today. While 3 million Americans have gout, this drug was developed for the tens of thousands whose disease doesn’t 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 the statement.
The company targets completing its resubmission in early 2010, Hamelin said. East Brunswick, New Jersey-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 refile, 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.
Savient’s only other drug, Oxandrin, for promoting weight gain after illness or surgery, began facing generic competition in December 2006.
Savient advanced 1.1 percent to $15.59 in Nasdaq Stock Market composite trading on July 31. The stock has gained 68 percent since the panel’s recommendation.
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