The RAPS store will be under maintenance Saturday, 29 February between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > NICE Recommends Genzyme’s Aubagio for MS

NICE Recommends Genzyme’s Aubagio for MS

Posted 09 December 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) on 6 December 2013 issued a final appraisal determination (FAD) recommending reimbursement for Genzyme's multiple sclerosis drug Aubagio (teriflunomide). 

The recommendation is for treatment of adults with active relapsing-remitting multiple sclerosis (RRMS), normally defined as two clinically significant relapses in the previous two years.

NICE is limiting its recommendation to patients who do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis, and conditioning it on an undisclosed discount on the drug, which has an annual cost of 13,529 pounds ($22,100) per patient.  Analysts estimate that Aubagio, which is approved in a number of other markets including the US, could generate €651 million ($891 million) in revenue by 2018.

The FAD has been sent to the consultees for the appraisal who have until December 20 to appeal it or highlight any factual errors. 


Read all Breaking News from RegLink

Tags: UK, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.