FDA grants priority review to Regeneron IL-1 Trap
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- August
- 10
Regeneron Pharmaceuticals Inc., a biopharmaceutical company based in Eastview, is one step closer to having its first marketable drug. The U.S. Food and Drug Administration has granted priority review status to its drug for a rare inflammatory condition. Rilonacept, which Regeneron calls the Interleukin-1 (IL-1) Trap, is designed to inhibit a disease-causing protein called Interleukin 1. It’s intended for the long-term treatment of CIAS1-Associated Periodic Syndromes (CAPS), which affects fewer than 200,000 people in the United States.
â€Ε“The FDA’s decision to grant priority review to rilonacept underscores the need for an effective therapy for patients suffering from this serious, debilitating disease,â€? Dr. Leonard Schleifer, president and chief executive officer of Regeneron, said in a written statement.
The FDA grants priority review to drugs that may offer a significant improvement in the safety or effectiveness of treatment for a serious or life-threatening disease. Regeneron said the FDA is expected to take action on this application by the end of November. If the review is positive, Regeneron would then have its first marketable drug.
This entry was posted
on Friday, August 10th, 2007 at 5:08 pm by Alison Bert.
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