Regeneron Pharmaceuticals, Inc . REGN and partner Sanofi SNY announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) as an add-on maintenance treatment in adults and adolescents (12 years of age or older) with moderate-to-severe asthma.

The FDA has set a target action date of Oct 20, 2018 per the Prescription Drug User Fee Act. The sBLA was supported by results from the three pivotal trials from the LIBERTY ASTHMA clinical development program.

We note that Dupixent was approved in the United States in March 2017 for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is also approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including the European Union, Canada and Japan.

Dupixent uptake in the United States for moderate-to-severe atopic dermatitis was encouraging. Dupixent sales came in at $139 million in the fourth quarter. A potential label expansion of the drug will further boost results.

Meanwhile, Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (phase III), nasal polyps (phase III) and eosinophilic esophagitis (phase III).

Regeneron's stock has lost 33.8% in the last six months compared with the   's 9.8% decline.

Regeneron's growth driver Eylea continues to perform well. Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG BAYRY . The   potential label expansion of Eylea in patients with wet age-related macular degeneration will further boost sales. The action date set by the FDA is Aug 11, 2018.

資料來源:

https://www.nasdaq.com/article/fda-accepts-regeneronsanofis-dupixent-sbla-for-asthma-cm930344