Regeneron/Sanofi's Dupixent Gets Positive CHMP Recommendation
Zacks Investment Research | Jun 30, 2019 11:00PM ET
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and partner Sanofi (NASDAQ:SNY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the label expansion of asthma drug, Dupixent.
The CHMP recommends label expansion of Dupixent in the European Union (EU) to include adolescents aged 12-17 years with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The positive opinion was based on data from the LIBERTY AD program, including a pivotal phase III trial and an open-label extension trial, evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis.
A final decision is expected soon.
Upon approval, Dupixent would be the first biologic medicine in the EU for this indication.
Dupixent is currently approved in the EU for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. It is also approved in the EU for patients aged 12 years or older as an add-on maintenance treatment for severe asthma with type 2 inflammation.
The drug is also approved for moderate-to-severe atopic dermatitis and asthma in the United States and Japan. The FDA recently approved the drug for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled. It is also under review in the EU for the same.
Meanwhile, Regeneron and Sanofi are also evaluating Dupixent in a broad clinical program for diseases driven by allergic and other type 2 inflammation, including pediatric asthma and atopic dermatitis (6 to 11 years of age, phase III), pediatric atopic dermatitis (6 months to 5 years of age, phase II/III), eosinophilic esophagitis (phase III), chronic obstructive pulmonary disease (phase III), and food and environmental allergies (phase II). The drug is also being studied in combination with REGN3500 (SAR440340), which targets IL-33.
Net sales of the drug, as recorded by Sanofi, came in at $373.7 million in the first quarter of 2019. Label expansion of the drug will diversify the company’s revenue base and reduce dependence on lead drug, Eylea.
Regeneron’s stock has lost 16% in the year so far against the Original post
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