London, UK, 6th June, 2006 – MRC Technology (London, UK) are pleased to learn that Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) yesterday announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for the reintroduction of TYSABRI® (natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses.
TYSABRI (an antibody-based therapy) was humanised on behalf of Elan at Medical Research Council Technology (MRCT) by the Antibody Engineering Group, now known as the Therapeutic Antibody Group (TAG). It is the second antibody humanised by these MRCT scientists to obtain regulatory market approval and one of eight antibodies humanised by TAG that have so far reached clinical trials.
TYSABRI has also received a positive opinion by Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), who recommended marketing authorization for TYSABRI as a treatment for relapsing-remitting MS. The CHMP’s positive recommendation for TYSABRI will be considered for final marketing approval by the European Commission which the companies anticipate will be later this year. TYSABRI is also awaiting the approval of a Marketing Authorisation Application for Crohn’s disease, which has also been filed with the EMEA.