Aubagio teriflunomide regulatory update
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). ...