Novartis' MS drug Extavia gains approval in EU

Swiss drugmaker Novartis AG announced Monday that the European Commission has approved its multiple sclerosis drug Extavia for the treatment of early and relapsing forms of multiple sclerosis (MS).

The multinational pharmaceutical group plans to launch Extavia in the U.S. and Europe in the first half of 2009.

"Novartis is committed to MS and to providing effective treatments for patients with this disease," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "The approval of Extavia means we are able to offer the MS community a current standard of care while preparing for the introduction of innovative therapies such as FTY720."

Formerly known as NVF233, Extavia is Novartis ' branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of MS. It is the first in Novartis’ new portfolio of medicines that is planned to include both established treatments and innovative therapies for patients with MS.

Extavia is the same medicine as Bayer AG's Betaseron, also known as Betaferon, which was the first beta interferon treatment for MS. Betaseron was approved in Europe in 1996 and generated $1.62 billion in worldwide sales last year that represents about 3 percent of Bayer's total revenue.

Basel, Switzerland-based Novartis and the Leverkusen, Germany-based drug maker Bayer settled a dispute over Betaseron in a deal that awarded the German Pharmaceutical company full control of the product while allowing Novartis to launch a similar drug in 2009.

EU’s approval had been widely expected after the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Extavia in March.

Novartis, Switzerland's second-biggest drugmaker, also recently filed for approval of interferon beta-1b with the US Food and Drug Administration.

"Results of an ongoing Phase II study extension presented in April show sustained benefits in patients with relapsing MS after three years of treatment with FTY720," Novartis said.

"Data showed that 68 percent to 73 percent of patients in the study remained free from relapses after three years' continuous treatment," the company said.

For the last more than 13 years, Interferon beta-1b has been established as a significant therapy with more than 700,000 patient-years' experience to date.

Multiple sclerosis, the chronic autoimmune disease, affects some 350,000 people in the U.S. annually and more than 2 million worldwide. The disease is more common among women than men and occurs most commonly in young adults.