HF-158K1

Regeneron and Sanofi’s blockbuster drug generated sales of $11.59bn in 2023, up 33% from the year before. Image credit: Shutterstock / Wildflower_macro. The approval of Regeneron and Sanofi ’s Dupixent (dupilumab) as the first targeted therapy for chronic obstructive pulmonary disease (COPD) has filled a biologics-shaped hole in the market, according to analyst reaction. The European Medicines Agency (EMA) greenlit the anti-inflammatory blockbuster drug earlier this week, marking the first advancement in the COPD space in more than a decade. GlobalData healthcare analyst Asiyah Nawab said: “The EMA’s approval of Dupixent has addressed a current gap in the market for COPD – the absence of biologics.” Dupixent, which targets interleukin-4 (IL4) and interleukin-13 (IL13), was approved by the EMA as an add-on maintenance treatment alongside current therapies. These include inhaled corticosteroids and bronchodilators, which control inflammation and relax and widen airways in the lungs. Nawab said that key opinion leaders (KOLs) interviewed by GlobalData have shared optimistic views on Dupixent, noting that its novel pathway presents anti-mucous effects – a bonus on top of its anti-eosinophil effects. See Also: HF-158K1 by HighField Biopharmaceuticals for Bladder Cancer: Likelihood of Approval Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity Nawab said: “The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with the potential to improve quality of life.” Dupixent is currently used to treat patients with severe asthma, atopic dermatitis, and other eosinophilic conditions as maintenance treatment. Full-year sales for the drug in 2023 generated $11.59bn, up 33% -from the year before. The COPD approval was based on data from two Phase III studies, named BOREAS (NCT03930732) and NOTUS (NCT04456673). In the two trials respectively, Dupixent led to 30% and 34% reductions in the rate of moderate or severe COPD exacerbations over 52 weeks. Nawab added: “KOLs have also communicated that the data presented in the clinical trials brings a great advantage to the asset and the COPD space, perhaps even over other biologics in the COPD pipeline.” The same day as the EMA issued a positive recommendation for the drug for COPD, Regeneron and Sanofi announced Dupixent’s US application for the same indication was delayed. The US Food and Drug Administration (FDA) pushed back its decision by three months, with a revised target action date of 27 September 2024. The agency did not raise concerns regarding the drug’s approvability prospects. Nawab said: “GlobalData’s Sales and Forecast database projects total sales of Dupixent to reach $23.6bn globally by 2030. With the EMA taking the first step of approving the first biologic for COPD and the FDA decision pending, the adoption of Dupixent for uncontrolled patients in the respiratory space will be closely watched.”