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Regeneron/Sanofi’s Dupixent Gets FDA Nod for Label Expansion

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Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the FDA has approved a label expansion of asthma drug Dupixent (dupilumab).

Dupixent, a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), is now approved for the treatment of adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

The FDA evaluated the Dupixent application under Priority Review. The drug was also granted Breakthrough Therapy designation for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. The approval was based on positive results from the phase III study, which showed that treatment with Dupixent significantly improved skin lesions, reduced itching and helped clear the skin of patients.

Hence, Dupixent is now approved for treating both adults and adolescents suffering from atopic dermatitis.


Dupixent’s uptake was strong in 2018 and the drug generated sales of $922 million.

A label expansion of the drug will further boost sales in 2019.

The FDA recently accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). A decision on the same is expected on Jun 26.

Dupixent is also approved in combination with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in patients aged 12 years or older whose asthma is not controlled with their current asthma medicines. Dupixent is also approved in other countries for use in certain adults with moderate-to-severe atopic dermatitis.

Meanwhile, both the companies are also evaluating dupilumab in a broad clinical development program on chronic rhinosinusitis with nasal polyps (phase III completed), pediatric (6 to 11 years of age) atopic dermatitis (phase III), pediatric (6 months to 5 years of age) atopic dermatitis (phase II/III), pediatric asthma (phase III), eosinophilic esophagitis (phase II/III), and food and environmental allergies (phase II).

The companies also plan to evaluate the drug for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN3500, which targets IL-33.

Regeneron’s stock has gained 6.6% in the past six months, against the industry’s decline of 13%.

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. 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 & Stock to Consider

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.

Celgene’s earnings per share estimates increased from $10.34 to $10.73 for 2019 over the past 30 days. Estimates for 2020 also increased 48 cents.

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