There was mixed news for Sanofi as the company’s oral MS drug Aubagio received a NICE recommendation while Lemtrada’s progress was slowed.
Sanofi, who had high hopes pinned on its duo of Multiple Sclerosis drugs to boost its sales, was given mixed blessings when the National Institute for Health and Care Excellence (NICE) approved oral drug Aubagio drug while calling for more data on Lemtrada.
Both MS treatments were recently granted EU approval with Sanofi in the midst of preparations to launch both drugs on the European market when the NICE decisions came through.
Aubagio – an oral MS treatment – finally secured approval from NICE following a comparison of the drug in certain combinations, deemed necessary in draft guidance released in September that questioned Aubagio’s effectiveness in front-line treatment. There was also an undisclosed price break offered by Sanofi to ease the deal.
Lemtrada was not so lucky, with NICE calling for more data on the medicine to fully assess its worth and setting Sanofi back with its plans for European release. This comes just weeks after the drug failed to impress the FDA, with staff members at the approval organisation raising concerns as to whether Sanofi’s clinical trials had been thorough enough to overlook “serious and potentially fatal safety issues”.