September 17, 2013

Genzyme MS Treatment Approved In Europe

Cambridge-based Genzyme, which has facilities in Northborough and Framingham, has announced the European approval of its second multiple sclerosis drug in less than a month.

The company today said it has been granted marketing approval for Lemtrada. That follows the Aug. 30 announcement of approval for Aubagio.

Genzyme said it plans to launch both products in the European Union soon.

"The approvals of Lemtrada and Aubagio in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients," said Genzyme President and CEO Dr. David Meeker. "This is particularly exciting as the EU approval is the first for Lemtrada globally."

Lemtrada will be used for adult patients who have relapsing remitting MS (RRMS) with active disease defined by clinical or imaging features. Patients treated with it receive the Lemtrada over five days, then over three days 12 months later. The treatment has been in clinical development for more than 10 years and involved more than 1,700 patients, Genzyme said. A decision of approval by the U.S. Food and Drug Administration is expected in late 2013.

Aubagio is a once-daily, oral therapy also for treatment of adult patients with RRMS. It is already approved in the United States, Australia, Argentina, Chile and South Korea, and is under review by other regulatory agencies, Genzyme said.

"Multiple sclerosis necessitates a highly individualized treatment approach, and the increasing diversity of options is good news," said Dr. Hans-Peter Hartung, professor and chairman of the department of neurology at Heinrich-Heine-University in Duesseldorf, Germany. "The Lemtrada clinical trial data support its potential to meaningfully address disability in active RRMS patients, while Aubagio's efficacy, safety and convenient dosing may provide an important alternative to injectable therapies. The approvals of Lemtrada and Aubagio represent a significant step forward in the way we think about treating this disease."

According to Genzyme, MS affects more than 2.1 million people around the world, with about 630,000 of those being in Europe.

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