Sanofi and Regeneron Seek FDA Approval of Dupixent as Add-On Asthma Therapy

Asthma patients may soon have a new treatment option. Pharma partners Regeneron Pharmaceuticals, Inc. and Sanofi US are betting their interleukin inhibitor will be a beneficial add-on maintenance for people with moderate-to-severe asthma.

The companies said the U.S. Food and Drug Administration accepted their supplemental Biologics License Application for the medicine to be considered as a treatment for patients ages 12 and up. The FDA is expected to make a decision by Oct. 20, the companies said.

Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 inflammation associated with moderate-to-severe asthma. Dupixent was approvedby the FDA last year as a treatment for atopic dermatitis. The same inhibiting action that makes it an effective treatment against atopic dermatitis, also makes it effective against asthma. Moderate-to-severe asthma is often associated with other Type 2 allergic inflammatory diseases. The disease is characterized by an imbalance or overactivity of certain immune cells and signaling proteins, which include IL-4 and IL-13, the companies said in their announcement.

Living with asthma can be difficult due to decreased lung functions. Those functions are further decreased when severe attacks occur, which can lead to hospitalization. In September George D. Yancopoulos, Regeneron’s chief scientific officer, said about one million adults and adolescents in the United States live with uncontrolled asthma – despite the number of treatment regimens they may be taking. Today Regeneron and Sanofi stressed that there is an "unmet need in patients who suffer from decreased lung function, severe exacerbations, long-term oral corticosteroid use and poor quality of life."

The companies said the BLA is supported by clinical data from nearly 3,000 participants in late-stage trials. In September 2017 the companies said Dupixent met its two primary endpoints in the Phase III Liberty Asthma Quest trial. When added to standard therapies Dupixent (dupilumab) reduced severe asthma attacks and improved lung functions, the companies said. After a year of adding Dupixent into the mix, trial data showed adding 300 mg of Dupixent reduced severe asthma attacks by 46 percent in the overall population. Additionally, the 300 mg dose reduced severe attacks by 60 percent to 67 percent in patients with high levels of eosinophilic cells across all levels.

The other Phase III trial, the Liberty Asthma Venture trial, showed that addition of Dupixent to standard therapies significantly reduced the need for maintenance oral corticosteroids by 70 percent on average, compared to 42 percent in the placebo group.

The companies said they intend to share full data from both trials at an upcoming conference.

Sanofi and Regeneron are exploring the efficacy of dupilumab in a number of mid- and late-stage programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (Phase III), nasal polyps (Phase III) and eosinophilic esophagitis (Phase II).

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