Sanofi and Regeneron Pharmaceuticals have received yet another approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Dupixent (dupilumab), this time as a treatment of chronic spontaneous urticaria (CSU).

The Japanese agency approved Dupixent in CSU patients ages 12 and older whose symptoms are inadequately controlled by H1-antihistamines. This is the first approval for the therapy in this indication.

Dupixent, a monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, has been a high-grossing drug for Sanofi and Regeneron. In 2023, the therapy netted $11.59bn in global sales in 2023, as per Regeneron’s financials. GlobalData forecasts Dupixent sales to maintain their upward trajectory and generate $20.4bn in sales in 2030.

Dupixent has been approved by the US Food and Drug Administration (FDA) and European Commission (EC) for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. Dupixent has been approved in Japan for all these indications except eosinophilic esophagitis.

Chronic spontaneous urticaria, also known as chronic hives, is a skin condition of an unknown cause that causes red, raised, and itchy hives that are occasionally painful. These hives last for six weeks or more and are managed symptomatically with anti-histamines, antipruritic, and anti-inflammatories.

The Japanese approval was based on the data from the Phase III LIBERTY-CSU CUPID Study A (NCT04180488). The 24-week placebo-controlled study compared the efficacy and safety of Dupixent as an add-on treatment to standard-of-care (SoC) of H1 antihistamines as against antihistamines alone.

The trial met its primary endpoint by demonstrating a 63% decline in itch severity compared to a 35% decline observed in the placebo arm. The improvement was maintained to week 24 of the trial. Dupixent also demonstrated a 65% decrease in the severity of urticaria activity (itch and hives), compared to a 37% reduction seen in the placebo arm.

The drug’s reach may expand to even more indications soon. It is also being investigated as a treatment for chronic obstructive pulmonary disease (COPD), and in November 2023, the companies reported positive interim data from the Phase III NOTUS trial (NCT04456673) showing a 34% reduction in exacerbations in COPD patients with Dupixent. The following month, Sanofi and Regeneron submitted a supplemental biologics licence application (sBLA) to both the FDA and the EU.

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