Novartis’ Extavia approved in US
pharmafile | August 19, 2009 | News story | Research and Development, Sales and Marketing |Â Â Extavia, MS, NovartisÂ
Novartis has received US approval for its betaferon product for multiple sclerosis.
Extavia’s active ingredient is interferon beta-1b, putting it into direct competition with other betaferons such as Bayer Schering’s Betaseron. This standard treatment for relapsing forms of MS is in the same class as Biogen’s Avonex and Merck Seronos Rebif.
Extavia was launched in January in Europe.
The US FDA has also approved it for patients whose MRI scan shows the first signs of the disease.
Joe Jimenez, chief executive of Novartis pharma division said: “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.
Interferon beta-1b has been shown to slow disease progression in some patients.
“With the approval of Extavia, patients have another option with a well-established safety and efficacy profile to help manage this disease,” said Doug Jeffery, associate professor at Wake Forest University Baptist Medical Center in North Carolina.
US patients on Extavia will also have access to a support programme including a nurse helpline, injection training and reimbursement support services.
The launch is part of Novartis’ expansion into the MS therapy area, and prepares the way for its novel, once-daily oral MS treatment, fingolimod. Novartis says FDA approval marks an important step forward, laying the foundation for an innovative approach to the treatment of MS.
Still in phase III clinical development, the innovative pill-form alternative to Extavia will offer advantages over established therapies if approved, and is expected to be filed later this year.
Novartis will face a challenge from Merck Serono’s cladribine, a similar treatment which has had encouraging new data this year. Teva, Biogen Idec and Sanofi-Aventis are also in the running to market rival oral MS treatments.
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