Thursday December 13, 3:17 pm Eastern Time
Press Release
SOURCE: Serono, S.A.
Serono to Participate in FDA Advisory Committee on Rebif(R)
GENEVA, and NORWELL, Mass., Dec. 13 /PRNewswire/ -- Serono, S.A. (NYSE: SRA and SWX Swiss Exchange: SEO) has received confirmation from the US Food and Drug Administration (FDA) that the agency will convene its Peripheral & Nervous System Drugs Advisory Committee regarding the pending Biologics License Application (BLA) from Serono for its multiple sclerosis drug Rebif® (interferon beta-1a). The Advisory Committee, which has reviewed all previously approved multiple sclerosis drugs in the US, is scheduled to meet on February 15, 2002.
``This is a very positive step forward in the review process for Rebif® and we welcome the opportunity to present important clinical data about Rebif® before the Advisory Committee,'' commented Ernesto Bertarelli, CEO of Serono. ``We continue to work closely with the FDA in order to bring Rebif® to people with multiple sclerosis in the US.''
Serono submitted additional clinical data to the FDA during Q3 2001 as an amendment to its original BLA seeking US marketing approval for Rebif® for the treatment of relapsing remitting multiple sclerosis.
Rebif® is approved in over 70 countries outside the US, including Canada, Germany, Spain, Switzerland and France. Rebif® is currently not approved in the US where another product holds Orphan Drug exclusivity.
Some of the statements in this press release are forward looking [snip] |
