Sanofi and Regenerons Dupixent has had a cakewalk to blockbusterland as it gobbles up share in the for-now wide-open atopic dermatitis market. But in severe asthma, where Dupixent sports another approval, the competition is fiercer, and pushback from England's cost watchdog won't help.
The National Institute for Health and Care Excellence (NICE) Monday chose not to recommend Dupixent to treat severe asthma, according to new guidance.
The watchdog knocked Dupixent's lack of head-to-head data in asthma against other available drugs on the market––including GlaxoSmithKline's Nucala, Teva's Cinqair and AstraZeneca's Fasenra––in its decision, and also said the drug didn't meet its cost-effectiveness standard Dupixent is currently listed for routine use by the National Health Service to treat severe atopic dermatitis, or eczema, at a list price of £1,264.89 for two prefilled syringes with a confidential discount, NICE said As part of that shift, Sanofi and Regeneron reworked their long-standing partnership on PCSK9 med Praluent and rheumatoid arthritis med Kevzara into a royalty-based agreement, with Regeneron taking over U.S. rights to the former and Sanofi snagging global rights to the latter.
The restructuring, however, didn't affect the pair's 50-50 split on Dupixent.
With Hudson forecasting rapid Dupixent growth, the drugmakers are looking at an early lead in an increasingly competitive––and lucrative––atopic dermatitis market.
With a possible €21 billion up for grabs, challengers like Eli Lilly and Incyte's Olumiant and Dermira's lebrikizumab are sporting late-stage data in atopic dermatitis. As of December, an additional 23 drugs were in some stage of development in the market, including Pfizer's abrocitinib, which posted winning phase 3 data in that indication in October.