Regeneron-Sanofi Get CHMP Nod for Dupixent Label Expansion

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Regeneron Pharmaceuticals, Inc . REGN and partner Sanofi SNY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Dupixent (dupilumab) in asthma.

The CHMP recommended Dupixent's approval for use in adults and adolescents aged 12 years or older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

The positive CHMP opinion was based on three pivotal trials from the global LIBERTY ASTHMA program, including the phase III QUEST and VENTURE trials.

The QUEST trial compared Dupixent to placebo in asthma patients inadequately controlled on a medium or high dose inhaled corticosteroid and a second controller medication, while VENTURE compared Dupixent to placebo in oral corticosteroid dependent asthma patients.

A decision from the European Commission is expected in the coming months.

We note that Dupixent is already approved in the European Union for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. A potential approval for asthma will broaden the sales potential of the drug.

In October 2018, the FDA also approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years or older, with an eosinophilic phenotype or oral corticosteroid-dependent asthma.

The uptake has been strong as Dupixent, in 2018 and the drug generated sales of $922 million.

Dupixent is being studied in pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy. Regeneron and Sanofi have also submitted an sBLA and a Marketing Authorization Application (MAA) for the label expansion of the drug, for the indication of atopic dermatitis in adolescent patients (aged 12-17 years).

The FDA has accepted for priority review the sBLA for atopic dermatitis in adolescent patients and set a target action date of Mar 11, 2019. A phase II/III study in eosinophilic esophagitis and a phase II study in peanut allergy have also been initiated. Data from two phase III studies of Dupixent in chronic rhinosinusitis with nasal polyps showed that the drug significantly reduced nasal polyp size, nasal congestion severity, and the need for systemic corticosteroid and/or surgery. Consequently, the company is planning to submit an sBLA for this indication as well.

Regeneron's stock has gained 8.1% in the past six months, against the industry 's decline of 11.5%.

While the overall biotech sector was in doldrums in 2018, Regeneron's performance has been steady, backed by strong growth of two drugs - Eylea and Dupixent. Regeneron's growth driver, Eylea continues to drive sales, and label expansion of the drug into additional indications has further boosted growth in 2018. The company has co-developed Eylea with the HealthCare unit of Bayer AG BAYRY .

Zacks Rank

Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Celgene Corp. CELG which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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