Savient Pharmaceuticals announced on Sunday that the FDA issued a complete response letter for the drugmaker's gout drug Krystexxa (pegloticase), causing the company's shares to fall 38 percent in premarket trading on Monday. Krystexxa is an enzyme designed for those who have not had success with or cannot use other treatments.
This comes as a major surprise for Savient and its investors, who pushed the company's shares up 50 percent back in June on an FDA panel's positive remarks on the much-watched drug. The advisory panel said the drug was safe and effective and should be approved. In its response letter, the FDA cited problems with the company's manufacturing procedures and safety data. According to Savient, the agency noted "deficiencies with the chemistry, manufacturing and controls" portion of the drugmaker's BLA and a change made in the planned commercial manufacturing process or Krystexxa the company laid out in its application.
Savient said it will request a meeting with the FDA to discuss the concerns and plans to re-validate the manufacturing process. "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," Savient CEO Paul Hamelin said in the statement.
- here's Savient's release
- read the Reuters report