Why did the FDA reject approval of Savients new gout drug?”
UPDATE 1-Savient plunges after FDA declines gout drug approval Mon Aug 3, 2009 10:28am EDT Aug 3 (Reuters) – Shares of Savient Pharmaceuticals Inc (SVNT.O: Quote, Profile, Research, Stock Buzz) fell 36 percent on Monday, a day after U.S. regulators declined to approve its experimental gout drug Krystexxa. Savient shares were down $4.21 to $11.38 in early-morning trade on Nasdaq. They earlier touched a low of $10. “Our confidence in Krystexxa ultimate approval remains high as the complete response letter included draft labeling and no requirement for additional clinical trials,” Cowen & Co analyst Eric Schmidt wrote in a note to clients. Savient said on Sunday the U.S. Food and Drug Administration issued a “complete response letter”, saying the agency cannot approve the drug at this time. The FDA cited “deficiencies with the chemistry, manufacturing and controls (CMC)” section of the company’s marketing application, Savient said. “There are five areas addressed within the complete respo
Ahead of the Bell: FDA rejects Savient gout drug FDA says Savient must address manufacturing issues for gout drug Krystexxa before approval * On Monday August 3, 2009, 6:46 am EDT NEW YORK (AP) — Shares of Savient Pharmaceuticals Inc. tumbled Monday after the Food and Drug Administration declined to approve its chronic gout treatment Krystexxa at this time, saying the company must tighten its manufacturing procedures and update safety data, among other items, before the agency can further review of the drug. Shares fell $5.89, or 38 percent, to $9.70 in premarket trading. Krystexxa, the proposed brand name of the drug pegloticase, is an enzyme intended to treat chronic gout in patients for whom other treatments have failed. Gout, a very painful form of arthritis, is caused by excess uric acid crystallizing and collecting around joints and tendons, causing debilitating inflammation. Savient said Sunday it will immediately request a meeting with the FDA to discuss the agency’s concerns
Related Questions
- What is the significance of the Food and Drug Administrations (FDA) approval of the OraQuick rapid HIV test for oral fluid on March 26, 2004?
- How the FDA Determines the "Safety" of Drugs Does FDA approval of a drug mean that the drug has been approved as safe for general use?
- Why did the FDA reject approval of Savients new gout drug?"
