Monday, March 22, 1993
FDA panel recommends use in MS patients
By Steve Usdin
ROCKVILLE, Md. - An FDA advisory committee on Friday recommended approval of Chiron Corp.'s and Berlex Laboratories' recombinant human interferon beta for patients with relapsing-remitting multiple sclerosis.
The Peripheral and Central Nervous System Drugs Advisory Committee's approval limited the indications for prescription of Betaseron to reduction of exacerbations "in patients with mild or moderate relapsing-remitting" MS, excluding more advanced, or progressive-chronic, cases of the disease that were not addressed in clinical trials.
Some 200,000 Americans suffer from relapsing-remitting MS, according to Stephen Reingold, vice president of research and medical programs at the National Multiple Sclerosis Society. Reingold said an additional 100,000 Americans are diagnosed with the progressive-chronic condition. He said Betaseron trials on this group will start soon.