NICE backs Sanofi's multiple sclerosis drug Aubagio in final guidance

The National Institute for Health and Care Excellence issued final guidance recommending Sanofi's Aubagio (teriflunomide) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS). Carole Longson, director of the agency's Health Technology Evaluation Centre, said "as an oral treatment with a different side-effect profile, [Aubagio] offers a new option for treating relapsing-remitting multiple sclerosis."

Aubagio was approved in Europe in August last year, with NICE provisionally backing use of the drug in December after asking Sanofi's Genzyme unit for further information on the effectiveness of the therapy. Specifically, Aubagio is recommended for patients if they do not have highly active or rapidly evolving severe RRMS and if the company provides the drug at an undisclosed discount under a patient access scheme. NICE noted that the list price of the product is 1037.84 pounds ($1718) per 28-tablet pack, with an estimated annual cost of 13,529 pounds ($22,392) per patient.

Sanofi's drug is the second oral MS treatment to be recommended for NHS reimbursement after NICE backed Novartis' Gilenya (fingolimod) in April 2012. William Sibold, head of MS at Genzyme, noted that Aubagio is the only oral MS drug to demonstrate an ability to slow the progression of disability in two trials. "That consistent efficacy is something that resonates very well with the community," Sibold remarked.

Sibold indicated that the drugmaker plans to target the 80 percent of MS patients who currently use injectable treatments, adding that Aubagio has "blockbuster potential." According to analysts, the product, which is approved in a number of other markets, including the US, may generate sales of 647 million euros ($877 million) in 2018.

For further information on the MS market, see Multiple Sclerosis: KOL Insight.

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