ARTICLE | Clinical News

Aubagio teriflunomide regulatory update

January 6, 2014 8:00 AM UTC

On Jan. 2, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Aubagio teriflunomide from the Genzyme Corp. unit of Sanofi has "no additional benefit" vs. interferon beta-1a to treat relapsing-remitting multiple sclerosis (RRMS). IQWiG said that there were no "relevant" differences in morbidity and quality of life between the 2 therapies, but said patients receiving Aubagio experienced diarrhea and alopecia more frequently, while patients receiving interferon beta-1a experienced flu-like symptoms and injection-site reactions more frequently. Comments are due Jan. 23, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in mid-March.

In December, the U.K.'s NICE issued a final appraisal determination (FAD) backing Aubagio for RRMS. The recommendation is contingent on Genzyme providing Aubagio at an undisclosed discount under a patient access scheme (see BioCentury, Dec. 9, 2013). ...