FDA Approves Novartis MS Drug

Earlier this week, the US Food and Drug Administration (FDA) approved Novartis Pharma’s (NVS - Snapshot Report) Extavia, a branded version of interferon beta-1b, which is used for the treatment of multiple sclerosis (MS). Novartis obtained the rights to seek approval for its own branded version of interferon beta-1b through agreements signed with Bayer Schering, which markets Betaseron.

MS is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibers that carry electrical signals in the brain. As a result, persons afflicted with the disease experience problems with muscle control and strength, vision, balance, sensation and mental function.

Extavia has been approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. It is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI).

Extavia is already available in 12 countries in the European Union where it is approved for relapsing-remitting MS as well as early MS (defined as a single demyelinating event with an active inflammatory process) and a steadily worsening form of the disease known as secondary progressive MS with relapses.

According to the National Multiple Sclerosis Society, there are approximately 400,000 MS patients in the US. Worldwide, MS is estimated to affect more than 2.5 million people.

Novartis will be launching Extavia this fall. Once launched, the product will be competing with Biogen Idec’s (BIIB - Analyst Report) Avonex and Tysabri, Teva Pharmaceuticals’ (TEVA - Analyst Report) Copaxone and Pfizer/Serono’s (PFE - Analyst Report) Rebif. Biogen is a leading player in the MS market with its Avonex posting sales of $2,203 million in 2008.

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