Label Expansion May Boost Regeneron’s Dupixent in the Future



Label expansion

In addition to atopic dermatitis (or AD), Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) are also exploring the use of Dupixent (dupilumab) in other indications such as asthma, pediatric AD, nasal polyps, and eosinophilic esophagitis. Dupixent may prove to be a major addition to the asthma segment, despite recent commercial launches of IL-5 (interleukin 5) inhibitors such as GlaxoSmithKline’s (GSK) Nucala, Teva Pharmaceutical’s (TEVA) Cinqair, and the expected future launch of AstraZeneca’s (AZN) benralizumab.

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Asthma indication

Dupixent is expected to not only improve lung function but also protect against future exacerbations in asthma patients who are also considered the allergic patient population. Data from a Phase 2b trial have demonstrated that Dupixent is effective in improving lung function as measured by forced expiratory volume measured during the first second (or FEV1) and reducing exacerbations, irrespective of the patient’s allergic classifications. The FDA (U.S. Food & Drug Administration) will consider this Phase 2b trial as a pivotal study in its approval process for Dupixent as an asthma indication.

Data from the fully enrolled Phase 3 trial Liberty Asthma Quest evaluating the efficacy of Dupixent in patients suffering from uncontrolled and persistent asthma, is expected in late 2017. If the data from this study are positive, Regeneron will file an application seeking FDA approval for Dupixent in the asthma indication in 4Q17.

Nasal polyps

Regeneron is also exploring Dupixent in the nasal polyps segment. After releasing positive data from its Phase 2 trial highlighting the efficacy of Dupixent in this indication, it started enrolling patients in two Phase 3 trials.

If Dupixent secures regulatory approval in the asthma and nasal polyps indications, it may have a favorable impact on Regeneron stock as well as the stock of the Health Care Select Sector SPDR ETF (XLV). Regeneron makes up about 1.2% of XLV’s total portfolio holdings.

In the next part of this series, we’ll see why Dupixent has been demonstrating efficacy across multiple allergic conditions.


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