Sanofi, Regeneron's Dupixent garners FDA approval for moderate-to-severe asthma

Sanofi and Regeneron Pharmaceuticals announced that the FDA approved Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Olivier Brandicourt, Sanofi CEO, said "there continues to be an unmet need for so many patients with moderate-to-severe asthma, and given that Dupixent works differently than other biologics, there is now a new treatment option for some of these patients."

Approval of Dupixent in this indication was based on a clinical trial programme including 2888 adult and adolescent patients with moderate-to-severe asthma in three studies for six months to one year. Sanofi and Regeneron noted that in the LIBERTY ASTHMA QUEST trial, results showed that Dupixent reduced severe exacerbations by 67 percent compared to placebo in patients with blood eosinophils of 300 cells/microliter or greater, and improved FEV1 by between 29 percent and 33 percent, versus 14 percent to 16 percent for placebo. Meanwhile, in a second study including severe, oral corticosteroid-dependent patients, Dupixent reduced average daily oral corticosteroid use by 70 percent compared to 42 percent with placebo.

George Yancopoulos, chief scientific officer of Regeneron, said "in the asthma clinical trial programme, Dupixent reduced severe exacerbations and oral corticosteroid use, improved quality of life and showed statistically significant and clinically meaningful improvements in lung function."  Yancopoulos added "following the approvals in atopic dermatitis and asthma, and recently announced positive Phase III results in chronic rhinosinusitis with nasal polyps, we are committed to advancing our broad development programme in additional Type 2 inflammatory diseases."

Sanofi and Regeneron said that for people with asthma, Dupixent comes in doses of 200 mg and 300 mg given every other week at different injection sites after an initial loading dose. The companies noted that the wholesale acquisition cost of the product, which comes in a pre-filled syringe and is intended for subcutaneous injection, remains unchanged and will be the same for both doses.

The biologic, which inhibits overactive signalling of IL-4 and IL-13, is approved in the US, EU and a number of other countries for the treatment of moderate-to-severe atopic dermatitis. Dupixent is also currently under regulatory review for moderate-to-severe asthma in several other markets, including Japan and Europe.

In the second quarter, sales of Dupixent reached 176 million euros ($203 million), up 576.9 percent, and beating expectations by 12 percent.

For related analysis, see Physician Views Results: Nucala retains its status of superiority in a growing asthma market.

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