And bad for BGEN (was predictable, but many didn't believed).
Related Quote
SRA 22.21 +2.62
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Quote Data provided by Reuters
Friday March 8, 4:00 am Eastern Time
Press Release
SOURCE: Serono, Inc.
Serono's rebif(R) Receives FDA Approval
Rebif(R) Gains Marketing Approval Under Terms of Orphan Drug Act By Demonstrating Clinical Superiority Over Avonex(R) at 24 Weeks in the EVIDENCE Head-To-Head Study
Rebif(R) Will Now Be Available to Patients With Relapsing Forms of Multiple Sclerosis in the US
ROCKLAND, Mass., March 8 /PRNewswire-FirstCall/ -- Serono, S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) 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.''
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, Avonex®, 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 the terms of the ODA by demonstrating clinical superiority over Avonex® at 24 weeks in the EVIDENCE head-to-head study.(2)
``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.'' <snip> |
