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FDA approves Extavia for MS

The FDA has approved Novartis' Extavia, its brand of Bayer's Betaseron, for the treatment of relapsing forms of multiple sclerosis

The US Food and Drug Administration (FDA) has approved Novartis' Extavia (interferon beta-1), its brand of Bayer AG's Betaseron, for the treatment of relapsing forms of multiple sclerosis (MS).

Patients with this form of the disease have new symptoms that occur suddenly or old symptoms that suddenly get worse. The injectable drug was also indicated for patients who have experienced a first clinical episode of MS, where symptoms are consistent with the disease.

Novartis gained rights to Extavia through its acquisition of Chiron Corporation in 2005, and in agreement with Bayer, who gained Betaseron with the 2006 purchase of Schering AG. Extavia received EU approval in May 2008 to treat early and relapsing forms of MS.

Bayer produces Extavia for Novartis and gets a "double-digit" percentage royalty from the Swiss drugmaker as part of an agreement between the companies. Extavia is reportedly the "first in a new planned portfolio" of MS medicines for Novartis.

The Swiss drugmaker said that about 400,000 people have MS in the US and around 80 per cent of patients have the relapsing-remitting type.

MS is a disease that causes the immune system to attack protective tissue around nerve fibres. This causes problems with muscle control and strength, vision, balance, sensation and mental function.

18th August 2009

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