UK's NICE calls for more information on MS treatment Aubagio

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), to provide more information on its multiple sclerosis drug Aubagio (teriflunomide), which has recently been approved by the European Commission (The Pharma Letter September 2).

In draft guidance published this morning (September 18) for consultation, the NICE has requested a series of clarifications on the evidence submitted by the manufacturer. The NICE has not yet published final guidance to the National Health Service.

The NICE is appraising 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. The independent Appraisal Committee, which develops the guidance on behalf of NICE, considered evidence from the manufacturer, clinical experts, patient representatives and an independent critique of the manufacturer’s submission.