Sanofi claims EU okay for Dupixent in asthma


Sanofi and partner Regeneron have picked up an approval in Europe for Dupixent in asthma, unlocking an important new indication for the fast-growing biologic.

Dupixent (dupilumab) – an interleukin-4 and 13 inhibitor – has been cleared by the EMA  for use in adults and adolescents 12 years and older as an add-on treatment for severe asthma with so-called type 2 inflammation, becoming the first biologic specifically indicated for this form of asthma.

Type 2 inflammation occurs in allergic-type diseases, and in the case of asthma is associated with elevated levels of eosinophils as well as high levels of fractional exhaled nitric oxide (FeNO), a marker for inflammation. The approval is for patients who can’t control symptoms using inhaled corticosteroids plus another maintenance drug.

The approval is another step on the way to what analysts say will become multibillion-dollar sales for Dupixent, a crucial growth product for both Sanofi and Regeneron. After a somewhat slow start last year, first-quarter 2019 sales of Dupixent rocketed $374 million, with growth driven by a US green light in asthma last year as well as new approvals that extended its use in atopic dermatitis – its first approved indication – to include adolescent patients.

The partners aren’t stopping there, with marketing applications already filed in the US and Europe for use of the antibody in other type 2 inflammatory diseases.

That includes chronic rhinosinusitis with nasal polyposis – with a verdict due from the FDA next month – while late-stage trials are ongoing in paediatric atopic dermatitis and eosinophilic esophagitis. Earlier-stage studies are also running in food and environmental allergies.

“In asthma, Dupixent is quickly establishing a competitive market presence [because] it has a differentiated clinical and safety profile compared to other asthma biologics,” according to George Yancopoulos, Regeneron’s chief scientific officer.

“It has a first-in-class mode of action that substantially reduces exacerbations and provides clinically meaningful improvement in lung function, for all the patient population, and is the only asthma biologic that can be self-administered,” he adds.

The market for biologic drugs for severe asthma is becoming increasingly crowded, with IL-5 inhibitors such as GlaxoSmithKline’s Nucala (mepolizumab), Teva’s Cinqair (reslizumab) and AstraZeneca’s Fasenra (benralizumab) all approved for eosinophilic asthma along with anti-immunoglobulin E drug Xolair (omalizumab) from Novartis/Roche.

Nevertheless, asthma is seen as key to Dupixent reaching its lofty sales targets, and Sanofi and Regeneron think its activity across multiple allergic diseases is an important differentiator from other biologics as patients often have more than one inflammatory condition.