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Regeneron & Sanofi Get FDA Nod for Dupixent Label Expansion

Zacks Equity Research

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

The drug is now approved for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled.

The FDA evaluated the Dupixent application for CRSwNP under priority review.

The FDA approval was based on encouraging data from two pivotal trials (the 24-week SINUS-24 and 52-week SINUS-52), which are part of the phase III LIBERTY clinical trial program. These trials evaluated Dupixent 300 mg every two weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared to placebo injection plus MFNS. Data from the trials showed that the drug significantly improved key disease measures, and met all primary and secondary endpoints. It significantly reduced nasal polyp size, and improved congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.

As a result of the latest approval, Dupixent is now approved for three conditions with underlying type 2 inflammation — moderate-to-severe atopic dermatitis, moderate-to-severe asthma and CRSwNP. The uptake has been strong for both atopic dermatitis and asthma. The drug is now annualizing more than $1 billion in net product sales in the United States alone. Label expansion of the drug in additional indications should further drive sales. 

The company is working to expand the drug’s label further into several other indications.

In addition to the currently-approved indications, 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). Dupixent is also being studied in combination with REGN3500 (SAR440340), which targets IL-33.

Label expansion of the drug will diversify the company’s revenue base and reduce dependence on lead drug, Eylea.

Last week, Regeneron and Sanofi announced that a phase II study evaluating their investigational IL-33 antibody, REGN3500 (SAR440340), in asthma met the primary endpoint.

Regeneron’s stock has lost 15.9% in the past six months, as against the industry’s growth of 2.6%.

 

The company’s efforts to develop its pipeline and diversify the revenues base are impressive. It earlier extended the collaboration agreement with Alnylam Pharmaceuticals, Inc. ALNY to discover, develop and commercialize new RNA interference (RNAi) therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.

Zacks Rank & A Stock to Consider

Regeneron currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same space is Gilead Sciences, Inc. GILD, which carries a Zacks Rank #2 (Buy), currently.  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Gilead’s earnings estimates have moved up by 24 cents to $6.89 for 2019, over the past 90 days.

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