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FDA Approves Novartis’ Extavia Therapy For Multiple Sclerosis

By Pharmaceutical Processing | August 17, 2009

The FDA has approved Extavia (interferon beta-1b), the first ina new planned portfolio of multiple sclerosis (MS) medicines from Novartis tohelp patients manage this devastating disease. Extavia is approved by the FDA for the treatment of relapsing forms of MSto reduce the frequency of clinical exacerbations. The therapy is alsoindicated for patients who have experienced a first clinical episode of MS andhave features consistent with the disease as shown by magnetic resonanceimaging (MRI). The same medicinal product as Betaseron, Extavia offers patients andphysicians a new branded version of interferon beta-1b, a first-linedisease-modifying therapy that has been a standard-of-care for MS in the USfor more than 16 years. Extavia will be marketed by the PharmaceuticalsDivision of Novartis. “Interferon is a mainstay of treatment in MS,” said Doug Jeffery, MD,Associate Professor at Wake Forest University Baptist Medical Center inWinston-Salem, North Carolina, USA. “With the approval of Extavia, patientshave another option with a well-established safety and efficacy profile tohelp manage this disease.” MS is estimated to affect approximately 400,000 patients in the US, ofwhom more than 80% have relapsing-remitting MS. MS is one of the mostcommon causes of neurological disability in young adults. It is a chronicautoimmune disease in which the body’s immune system attacks the myelinsheath, or protective tissue surrounding the nerve fibers that carryelectrical signals in the brain. The destruction of myelin causes problemswith muscle control and strength, vision, balance, sensation and mentalfunction. “Novartis has been a leader in neuroscience for more than 50 years, havingpioneered a number of breakthrough therapies which remain important treatmentsto this day,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division.”We are committed to providing new approaches to MS care, and the FDA approvalof Extavia marks the beginning of our long-term commitment to the MS communityin the US.” Extavia will be available to patients in the US this fall. Along withtheir prescription for Extavia, patients will be given access to a supportprogram including a nurse helpline, one-on-one injection training andreimbursement support services. Extavia patients will have an autoinjectoravailable to them from Novartis.

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