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Novartis gets MS drug approval

Novartis has announced that the European Commission has granted approval for its new multiple sclerosis (MS) treatment, Extavia, and has said it intends to continue broadening its product range in this therapeutic area.

Novartis has announced that the European Commission has granted approval for its new multiple sclerosis (MS) treatment, Extavia, and has said it intends to continue broadening its product range in this therapeutic area.

Extavia is the same as the MS treatment Betaferon/Betaseron manufactured by Bayer-Schering, Betaferon/Betaseron. The company obtained the rights to produce its own branded version of the generic drug, interferon beta 1b, through an agreement with Bayer-Schering related to the 2006 acquisition of Chiron, a California based pharmaceutical company.

The drug is now indicated for the treatment of relapsing-remitting MS in the EU and Novartis has filed for approval with the US Food and Drug Administration. Interferon beta 1b based medicines reduce the frequency of MS attacks.

Dr Trevor Mundel, head of global development functions at Novartis explained that the company is committed to providing MS patients with efficacious treatments.

"The approval of Extavia means we are able to offer the MS community a current standard of care while preparing for the introduction of innovative therapies, such as FT720," he said.

Studies into FT720 (fingolimod) a potential treatment option for relapsing MS have shown that 68 to 73 per cent of patients being given the drug during trials remained free from relapses after three years of continuous treatment. Novartis plans to make an application for approval in the EU by the end of 2009.

27th May 2008

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