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Published on 17 August 2009

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US FDA approves Extavia

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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 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 (MRI).

The same medicinal product as Betaseron, Extavia offers patients and physicians a new branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for MS in the US 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.”

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 Joe Jimenez, CEO of the Novartis Pharmaceuticals Division.

“We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US.”

Extavia will be available to patients in the US 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. Extavia patients will have an autoinjector available to them from Novartis.

“MS is unpredictable and can be difficult to manage,” said Aaron Miller, Professor of Neurology at Mount Sinai School of Medicine in New York, USA. “Support programs are an essential element to help patients and physicians effectively manage this complicated disease.”

MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (known as exacerbations or relapses), followed by complete or partial restoration of function.

Interferon beta-1b has been shown to reduce annualized relapse rates by 34% (p=0.0001), with patients nearly twice as likely to remain relapse-free for more than two years compared to those receiving placebo (31% vs. 16%, p=0.007). In addition, treatment with interferon beta-1b may slow disease progression. After two years, almost three-quarters of patients who experienced a single episode of neurological disease lasting 24 hours or more did not progress to clinically definite MS.

Novartis



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