The latest set of opinions from advisors to the European Medicines Agency has resulted in a pile of recommendations for approvals, notably for multiple sclerosis pills from Biogen Idec and Sanofi.
First up, the agency's Committee for Human Medicinal Products (CHMP) has backed approval for Biogen's Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting MS. The recommendation comes just as the US Food and Drug Administration is expected to make a decision on the drug which analysts believe will be a blockbuster. Tecfidera will follow Novartis’s well-established Gilenya (fingolimod) onto the oral MS market but the Biogen drug has shown impressive safety and efficacy in trials.
Staying with MS and the CHMP also issued a positive opinion on Sanofi's Aubagio (teriflunomide). However, the committee did not recommend that the drug receive a new active substance designation, which could mean that generic firms may develop versions of the treatment which is already available across the Atlantic and is selling well.
David Meeker, head of Sanofi's Genzyme unit said “we are very disappointed about the CHMP opinion regarding new active substance designation", noting that Aubagio has been studied over 10 years "in one of the largest and broadest clinical development programmes of any MS therapy". He added that the decision "could have a detrimental impact on future scientific innovation in MS and other diseases", noting that "we are considering all options and planning to request a re-examination of the new active substance designation".
The CHMP also recommended approval of Gilead Science's four-drug HIV treatment Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir), which was formerly known as Quad and was approved in the USA in August. Positive opinions were also issued for Ariad's Iclusig (ponatinib) for two rare types of leukaemia and Baxter/Halozyme's HyQvia immune globulin product HyQvia.
In terms of label expansions, the EMA's advisors backed Bayer's Xarelto (rivaroxaban) for the prevention of atherothrombotic events in adults after an acute coronary syndrome, weeks after the FDA rejected the drug in that indication. The CHMP also backed extended use of Roche's Mabthera (rituximab), Alexion's Soliris (eculizumab) and Gilead's Viread (tenofovir) and confirmed a negative opinion on Gentium's Defitelio (defibrotide) for hepatic veno-occlusive disease.