Serono S.A. reported 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, CEO of Serono. "This is a great day to celebrate Serono's commitment to science and clinical advancement."

In the treatment of relapsing forms of multiple sclerosis, Rebif decreases the frequency of clinical exacerbations and delays the accumulation of physical disability 1. Until now, Rebif could not be marketed in the US due to the Orphan Drug status of another interferon beta-1a product, whose exclusivity under the Orphan Drug Act (ODA) was granted in 1996 and will not expire until May 2003. Rebif was able to gain marketing approval under section 316.3 of the ODA regulations by demonstrating "clinical superiority" over the other interferon beta-1a product at 24 weeks in the Evidence head-to-head study 2.

1 Prisms (Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in MS) Study Group. Randomized, double-blind, placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-1504.

2 Evidence: Evidence for Interferon Dose-response European-North American Comparative Efficacy.

"The approval of Rebif is good news for people with multiple sclerosis in the US," said Patricia K. Coyle, MD, Health Science Center, State University of New York at Stony Brook. "Physicians are now free to prescribe Rebif to patients in the US who have relapsing forms of multiple sclerosis."

Multiple sclerosis is a chronic, inflammatory condition of the central nervous system. It is the most common non-traumatic disease of the central nervous system in young adults and today affects approximately 350,000 people in the US. While symptoms can vary from person to person affected by MS, common symptoms include: blurred vision, numbness and tingling in the limbs and problems with strength and coordination. The relapsing forms of the disease are the most common forms of MS.

The Evidence study 3 is the largest prospective, randomized comparative study of two disease modifying drugs in RRMS to date. The open-label, assessor-blinded study included 677 patients with RRMS who had not been treated with interferon before, ages 18-55, at 56 centers in the US, Canada and Europe. Patients underwent repeated clinical and MRI assessments while taking either interferon beta-1a 44 mcg three times weekly, subcutaneously (Rebif) or the other interferon beta-1a product 30 mcg once weekly, intramuscularly. During the study, assessing neurologists and radiologists were blinded from knowing which drug the patients were taking.