Here's a nice bit of news... WARREN, N.J., Oct. 23 (Reuters) - Celgene Corp (Nasdaq:CELG - news) has received ''orphan drug designation'' from the FDA for its thalidomide drug as a treatment for the blood cancer, multiple myeloma, the company said Friday.
Orphan drug designation by the Food and Drug Administration is intended to encourage research and development of new therapies for diseases affecting fewer than 200,000 Americans. It provides for seven years' marketing exclusivity following the FDA approval of an orphan drug designated indication.
Celgene said the FDA designation for its lead compound, Thalomid -- the company's brand name for thalidomide -- means it could carry out clinical tests but not yet market the drug as a treatment for multiple myeloma.
In July, Celgene received FDA approval to market and sell Thalomid to treat a side-effect of leprosy known as erythemas nodosum leprosum, a painful condition that causes bumps under the skin. The drug, available since Oct. 1 for the leprosy indication, is also being tested as a treatment for other diseases, including AIDS-related conditions, Celgene's President and Chief Operating Officer Sol Barer told Reuters. |