Sanofi/Regeneron's Dupixent Rejected by NICE for Severe Asthma Due to Cost-Effectiveness Concerns

Text | Fan Dongdong

Dupixent, the blockbuster drug from Sanofi and Regeneron, has captured the majority of the market share for atopic dermatitis. However, in terms of asthma indications, despite Dupixent's approval, intense competitive pressure has made its expansion appear less than smooth.

Recently, the UK's National Institute for Health and Care Excellence (NICE) announced that it does not recommend Dupixent for the treatment of severe asthma.

NICE stated that Dupixent lacks head-to-head comparative trial data against other asthma medications available on the market, including GlaxoSmithKline’s Nucala, Teva’s Cinqair, and AstraZeneca’s Fasenra, and determined that the drug does not meet cost-effectiveness criteria; therefore, it decided not to recommend Dupixent for the treatment of severe asthma.

NICE stated that Dupixent has currently been listed as a routine medication by the UK’s National Health Service for the treatment of severe atopic dermatitis or eczema, with two pre-filled syringes priced at £1,264.89, subject to a confidential discount. NICE’s recent refusal to recommend the drug will cause some setbacks to Sanofi and Regeneron’s goal of achieving annual sales of €10 billion for Dupixent in the coming years.

Dupixent is an antibody drug targeting the IL-4 receptor α, capable of simultaneously binding to and blocking IL-4 and IL-13 signaling. In March 2017, the drug received approval from the U.S. FDA, becoming the first biologic agent for the treatment of moderate-to-severe atopic dermatitis. In October 2018, the FDA approved Dupixent as an add-on maintenance therapy for adolescent and adult patients aged 12 years and older with moderate-to-severe asthma, specifically including two subtypes: eosinophilic phenotype asthma and oral corticosteroid-dependent asthma.

In December 2019, Sanofi CEO Paul Hudson announced that the company would concentrate its efforts on six key therapeutic areas, including hemophilia, oncology, hematology, rare diseases, and neurology, while excluding diabetes and cardiovascular diseases. Sanofi is currently placing significant emphasis on Dupixent and will launch multiple initiatives this year to vigorously promote the drug, including expanding into new indications and new markets. Hudson projected that Dupixent’s sales would grow from €2.07 billion in 2019 to €10 billion in 2020.

Although Hudson predicted the rapid growth of Dupixent, other pharmaceutical companies are also accelerating their search for competitive opportunities. As of last December, there were 23 related drugs in development. Notably, Pfizer’s abrocitinib achieved positive Phase 3 trial results last October. Other strong competitors include Olumiant, developed by Eli Lilly and Incyte, and Dermira’s lebrikizumab.

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