FDA Approves Pfitzer's Rebif for the Treatment of Relapsing Forms of Multiple Sclerosis

This March, the U.S. Food and Drug Administration (FDA) approved Rebif, a form of interferon beta-1a manufactured by Serono, for treatment of relapsing forms of MS. With the addition of Rebif, there are now five drugs--Avonex, Betaseron, Copaxone, Novantrone, and Rebif--approved in the United States for modifying the course of major forms of MS. Avonex, Betaseron, Copaxone, and Rebif are approved for relapsing forms of MS; Novantrone is approved for progressive as well as rapidly worsening relapsing forms of MS.

The FDA approval was based on results from two clinical trials: the PRISMS study and the EVIDENCE study. Since the results from the PRISMS trial were first announced in 1997, Rebif has been prescribed for MS in over 60 countries worldwide. Rebif is taken by subcutaneous (under the skin) injection three times a week.

Serono, S.A. announced today that the US Food and Drug Administration (FDA) has approved Rebif® (interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis. This approval was based upon the results of two large multi-center studies in patients with relapsing remitting multiple sclerosis (RRMS). The data collected in the PRISMS and EVIDENCE studies, along with years of clinical experience with Rebif outside the US, have shown that Rebif provides significant treatment benefits for people with relapsing forms of MS.

"This is an important milestone for our company. The FDA approval, based upon all the evidence, enables us to make Rebif available to people in the US with multiple sclerosis," said Ernesto Bertarelli, Chief Executive Officer of Serono. "This is a great day to celebrate Serono's commitment to science and clinical advancement."

Rebif (interferon beta-1a) has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis. Rebif has been shown to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with MS. The recommended dose of the product is 44 mcg three times per week to be administered by subcutaneous injection. Rebif is supplied in single-use, pre-filled syringes.