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Novartis wins European approval for multiple sclerosis drug

Novartis has announced that the European Commission has approved Extavia for the treatment of early and relapsing forms of multiple sclerosis. The drug is said to be the first in a new portfolio of medicines from Novartis that is planned to include both established treatments and innovative therapies for patients with multiple sclerosis.

Extavia is the Novartis branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of multiple sclerosis (MS). Formerly known as NVF233, Extavia is the same medicine as Betaferon or Betaseron, which is marketed by Bayer-Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer-Schering related to the acquisition of Chiron.

Novartis also recently filed for approval of interferon beta-1b with the FDA. Launches in the US and EU are planned for the first half of 2009, in line with an agreement with Bayer-Schering that established the opportunity for Novartis to introduce its own branded version of interferon beta-1b. By the end of 2009, Novartis also plans to file for approval of the innovative oral therapy FTY720 (fingolimod).

In the EU, Extavia is approved for patients with relapsing-remitting MS, the most common form of the disease involving relapses followed by complete or partial restoration of function, and for a steadily worsening form of the disease known as secondary progressive MS with relapses.