Keywords: Multiple Sclerosis, MS, Novartis, Extavia

Novartis Multiple sclerosis drug Extavia cleared by US FDA

Article | 17 August 2009

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The US Food and Drug Administration (FDA) has approved Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

Extavia, acquired by the Swiss firm as part of its purchase of Chiron in 2005, is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy 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. The drug was cleared for marketing in the European Union in May 2005.

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The same medicinal product as Betaseron (interferon beta 1), which Germany’s Bayer agreed could be sold under a different name by Novartis, Extavia offers patients and physicians a new branded version of a first-line disease-modifying therapy that has been a standard-of-care for MS in the USA for more than 16 years. Extavia will be marketed by the Pharmaceuticals Division of Novartis.

"Interferon is a mainstay of treatment in MS," said Doug Jeffery, Associate Professor at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, USA. "With the approval of Extavia, patients have another option with a well-established safety and efficacy profile to help manage this disease," he added.

This is a strategic step for Novartis to establish itself in the MS market before introducing its potentially best-selling FTY720 MS pill. The company aims for at least $1 billion in sales for its multiple sclerosis franchise, Joe Jimenez, the chief executive of Novartis Pharmaceuticals Division, said in an interview with the Bloomberg news service before the approval.

MS is estimated to affect approximately 400,000 patients in the US, of whom more than 80% have relapsing-remitting MS. MS is one of the most common causes of neurological disability in young adults. It 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. The destruction of myelin causes problems with muscle control and strength, vision, balance, sensation and mental function.

"Novartis has been a leader in neuroscience for more than 50 years, having pioneered a number of breakthrough therapies which remain important treatments to this day," said Mr Jimenez in a statement announcing the approval.

Extavia will be available to patients in the USA this fall. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training and reimbursement support services.