NICE questions benefit of Genzyme’s multiple sclerosis drug

The UK's National Institute for Health and Care Excellence (NICE) has requested Sanofi's Genzyme to provide more information on its multiple sclerosis (MS) drug Aubagio.

NICE's independent Appraisal Committee is currently appraising Aubagio (teriflunomide) as a treatment for adults with relapsing-remitting multiple sclerosis. This is a chronic, disabling, neurological condition that, as it progresses, can be life altering and have a substantial negative impact on quality of life and activities of daily living.

"When reviewing the evidence for teriflunomide, the Appraisal Committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with relapsing-remitting multiple sclerosis. This is why we have requested more details from the manufacturer; we want to ensure that we have as much information as possible to make an informed final recommendation."

Sir Andrew Dillon, NICE Chief Executive.

Genzyme has until Tuesday 8th October 2013 to submit this extra information to NICE. The committee will then review the extra evidence and develop further draft guidance. Final guidance on the use of teriflunomide as a treatment for relapsing-remitting multiple sclerosis is expected to be published in January 2014.

Aubagio was approved for use in the European Union on the 30th August 2013. This week, the European Commission has also granted marketing authorization for Genzyme's other multiple sclerosis drug, Lemtrada (alemtuzumab).

Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

"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. This is particularly exciting as the EU approval is the first for Lemtrada globally. We look forward to making these unique therapies available to MS patients very soon."

Genzyme CEO and President, David Meeker, M.D.

Multiple sclerosis is estimated to affect more than 2.1 million people globally and there are approximately 630,000 people affected by MS in Europe.