(News Bulletin 247) – Sanofi’s Dupixent has been approved by the European Medicines Agency to treat chronic obstructive pulmonary disease in adults. This is the seventh indication for the drug worldwide.

Sanofi’s blockbuster Dupixent has been given a new indication. The European Medicines Agency has given it the green light for the add-on maintenance treatment of adults with uncontrolled chronic obstructive pulmonary disease (COPD), characterized by elevated blood eosinophilia.

Nicknamed “smoker’s bronchitis,” COPD is a life-threatening respiratory disease that damages the lungs and leads to a progressive decline in respiratory function. Symptoms include chronic cough and shortness of breath, which can not only affect the ability to perform daily activities, but also cause anxiety, depression, and sleep disturbances.

According to Sanofi, 220,000 adults are affected by this disease in the European Union.

The approval by the European Medicines Agency was based on the phase III studies (the final stage of clinical trials before potential marketing) “Boreas” and “Notus” which had been published in the scientific journal “The New England Journal of Medicine”.

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Trying to reduce dependence on Dupixent

These studies had, to summarize, reported in particular an improvement in respiratory quality and quality of life following treatment compared to a placebo.

The European Medicines Agency is the first health authority to approve Dupixent for this indication. The company has submitted other applications for this indication, including in the United States, China and Japan.

On the Paris Stock Exchange, Sanofi shares fell slightly (-0.1%) around 3:20 p.m., in a context of risk appetite that could penalize defensive stocks such as those in healthcare, with the CAC 40 gaining 1.4% at the same time.

Dupixent now has seven indications worldwide. The drug is approved to treat atopic dermatitis, asthma and chronic urticaria.

In December, Sanofi said it expected Dupixent sales to grow at least 10% on average annually between 2023 and 2030. Last year, sales totaled €10.72 billion, up 29%. According to UBS’s calculations, Dupixent could reach total sales of €21.5 billion in 2030.

While Dupixent is a proven success for Sanofi, the clinical failures of recent years (for example, the abandonment of the development of amcenestrant against breast cancer in 2022) and the group’s not always successful acquisitions have led the market to question the dependence of its growth on this drug.

The company has decided to redouble its efforts in R&D and in December presented 12 molecules in the clinical trial phase, each with a sales potential of between 2 billion euros and 5 billion euros per year at cruising speed.

Sanofi expects to submit these molecules for regulatory authorizations between 2024 and 2027 for five of them and beyond 2027 for the other seven.