Sanofi, Regeneron's Dupixent hits setback at NICE in severe asthma

Dupixent package
Sanofi and Regeneron's Dupixent is available on the National Health Service to treat atopic dermatitis. (Sanofi)

Sanofi and Regeneron's 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. 

RELATED: Dupixent sales of €10B? We're on track, Sanofi CEO Hudson says

The NICE knockdown comes as a setback in Sanofi and Regeneron's plan to turn Dupixent into a €10 billion-a-year sales steamroller in the coming years.

In early February, Sanofi CEO Paul Hudson said the partners were planning 89 Dupixent launches in 2020, a number that includes new indications and new markets, or both. The drug is currently approved in eczema, asthma and nasal polyps, and it hit  €2.07 billion in sales last year. Plus, it's been growing at about €100 million per quarter, Hudson said.

Dupixent was at the heart of a Sanofi reorientation Hudson announced in December, pivoting the drugmaker away from diabetes and cardiovascular meds and toward rare diseases, oncology and its immunology blockbuster.

RELATED: Sanofi, Regeneron uncouple on long-standing drug partnership, splitting up Praluent, Kevzara

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.