Savient says FDA declined to approve gout drug
NEW YORK (Reuters) - Savient Pharmaceuticals Inc said on Sunday the U.S. Food and Drug Administration declined to approve its gout drug Krystexxa and that it seeks to resubmit its application to the FDA by early 2010.
The company has been seeking FDA approval for the infused drug, for those who have the painful type of arthritis, but do not improve with other treatments or cannot take the alternatives for various reasons.
Investors have been keenly watching the drug's progress. Savient's shares soared in June when a U.S. advisory panel said the drug is safe and effective for certain patients with the debilitating joint disorder and should be approved.
The FDA cited "deficiencies with the chemistry, manufacturing and controls" section of Savient's Biologics License Application, Savient said in Sunday's statement. It also raised as an issue a change made by Savient in the proposed process for manufacturing Krystexxa for commercial use.
Savient has the option of either validating the manufacturing process used to produce the drug or conducting additional comparability clinical trials, it said. It added that it expects to revalidate the manufacturing process.
The company said it intends to immediately request a meeting with the FDA to discuss the issues.
"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 2010," said Savient President Paul Hamelin said in the statement.
Roughly 5 million Americans have gout, in which uric acid build-up can cause swollen joints. Of those, about 40,000 to 60,000 see no improvement with other therapies, Savient has previously said.
Doctors can prescribe a variety of medications for gout, including corticosteroids painkillers known as non-steroidal anti-inflammatory drugs. A number of other drugs are also available, including allopurinol, probenecid and Takeda Pharmaceutical Co Ltd's recently approved Uloric. Allopurinol and probenecid are made by a variety of companies.
(Reporting by Megan Davies; Editing by Richard Chang)
