Serono seeks FDA approval for Rebif. (News).

Serono, Inc., the Swiss manufacturer of Rebif (interferon beta-1a), has announced that it will take the results from a recent clinical trial comparing Rebif with Avonex (interferon beta-1a) to the Food and Drug Administration as part of a bid to get FDA approval for the sale of Rebif in the United States. Rebif cannot currently be marketed in the U.S. because of the "orphan drug" status of Avonex. FDA regulations provide a seven-year market protection for new drugs found to be effective for "orphan" disorders, unless clinical superiority from a competitive product can be demonstrated. Unless the FDA issues a new ruling, Rebif cannot be marketed here until mid-2003.

Rebif vs. Avonex

The results of a six-month trial, called the "EVIDENCE" study, were presented in June 2001 by Dr. Patricia Coyle of the State University of New York, Stony Brook, at the World Congress of Neurology in London.

The study included 677 participants with relapsing-remitting MS. Half were given standard doses of Rebif (44 mcg, injected subcutaneously, three times a week), and half received Avonex (30 mcg, injected intramuscularly, once a week). Of those treated with Rebif, 25.1% had MS relapses during the six-month study period, compared with 36.7% of those who were given Avonex. The study also showed that those talking Rebif had 50% fewer "combined unique lesions" in the brain than those talking Avonex. Other measured outcomes relating to relapses and imaging also favored Rebif.

FDA approval?

Within the limits of this relatively short clinical trial, Rebif appears to have performed better than Avonex on several measures. The comparative performance of the two interferons on a long-term basis is not yet known. The FDA's decision on an early approval of Rebif is pending.