MRC Technology (MRCT) was delighted to learn that Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) were granted Accelerated Approval from the US Food and Drug Administration (FDA) for the use of TYSABRI, formerly known as ANTEGREN (natalizumab), as treatment for relapsing forms of multiple sclerosis and have launched the new product. TYSABRI was “humanised” on behalf of Elan by the Antibody Engineering Group in MRCT's laboratories at Mill Hill, London, then known as MRC Collaborative Centre. It is the first antibody humanised by MRCT scientists to obtain regulatory market approval. TYSABRI is one of seven humanised antibodies developed by MRCT scientists on behalf of its collaborators that have reached clinical trials.
Antibody humanisation, also known as CDR-grafting was invented at the Medical Research Council (MRC) Laboratory of Molecular Biology in the UK by Sir Greg Winter and first patent applications were filed by the MRC in 1986. The technique, which overcomes the common human reaction to mouse antibodies, revolutionised the use of antibodies for human treatment and diagnosis. Antibody humanisation involves the genetic transfer of the active parts of mouse antibodies into human immunogloblins to make antibodies that minimise the anti-mouse reaction. A total of nine therapeutic humanised antibody products have now been approved by the FDA.