The US Food and Drug Administration (FDA) has approved Novartis' Extavia, a new treatment for multiple sclerosis (MS).
Extavia is 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.
The new drug has been approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations and to treat patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging.
Novartis Pharmaceuticals Division CEO Joe Jimenez said that the company was committed to providing new approaches to MS care.
"FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US," Jimenez said.
Interferon beta-1b has been shown to reduce annualised relapse rates by 34%, with patients nearly twice as likely to remain relapse-free for more than two years compared to those receiving placebo.
MS is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibres that carry electrical signals in the brain, and is estimated to affect approximately 400,000 patients in the US.
Extavia will be available to patients in the US towards the end of 2009.