Sanofi ($SNY) and R&D partner Regeneron ($REGN) could have their experimental IL-6 inhibitor sarilumab approved in Europe by early 2017.
The French Big Pharma and the U.S. biotech said the European Medicines Agency has today accepted for review their marketing app for sarilumab--an IL-6 inhibitor mAb that wants a blockbuster license for rheumatoid arthritis (RA).
The drug is already on the FDA’s books, with the U.S. regulator set to make a decision on whether to approve the med by the end of October.
Things are looking good for the pair--which have been ramping up the R&D deals between them over the past two years--as sarilumab recently bested AbbVie's ($ABBV) top-selling autoimmune TNF blocker Humira (adalimumab) in a Phase III head-to-head study in RA.
Humira, the biggest-selling med in the world, made around $14 billion last year and has a host of licenses including rheumatoid arthritis, moderate to severe plaque psoriasis, psoriatic arthritis and others.
The drug is, however, set to see its sales hit in the coming years with a slew of cheaper biosimilars waiting in the wings to usurp its top-selling drug spot.
Sarilumab would become the second approved product to come out of from Sanofi's wide-ranging partnership with Regeneron, following on from its launch of Praluent (alirocumab), an antibody designed to clear out bad cholesterol by blocking a protein called PCSK9.
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