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Regeneron’s Dupixent Approved for Atopic Dermatitis

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Dupixent approval

In March 2017, the US Food and Drug Administration (FDA) approved Sanofi’s (SNY) and Regeneron Pharmaceuticals’ (REGN) Dupixent (dupilumab) for the treatment of individuals with moderate to severe atopic dermatitis who did not adequately respond to topical therapies or for subjects who are not advised to undergo those therapies.

In September 2017, the EC (European Commission) approved the marketing authorization for Dupixent for the same indication.

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Clinical trial outcomes

Regeneron Pharmaceuticals conducted the global LIBERTY AD clinical program, which consisted of three phase three pivotal trials: SOLO 1, SOLO 2, and CHRONOS.

The SOLO 1 trial met its primary endpoint where 38% of patients receiving 300 mg of Dupixent every two weeks achieved clear or almost clear skin evaluated by the five-point Investigator’s Global Assessment (or IGA) scale compared to 10% for patients on a placebo.

The SOLO 2 trial met its primary endpoint where 36% of patients receiving 300 mg of Dupixent achieved clear skin or almost clear skin compared to 9% of patients on placebo therapy.

In the SOLO 1 and SOLO 2 trials, at 16 weeks, 51% and 44% patients, respectively, receiving Dupixent 300 mg every two weeks achieved EASI-75 (75% reduction in Eczema Area and Severity Index score) compared to 15% and 12% of patients who were receiving placebo therapy.

The CHRONOS trial met its primary endpoint where 39% of the patients receiving Dupixent 300 mg every two weeks achieved clear skin or almost clear skin compared to 12% of patients on placebo and topical corticosteroid therapy. In the CHRONOS trial, 69% of patients on Dupixent 300 mg achieved EASI-75 compared to 23% of patients on placebo and topical corticosteroids.

The superior clinical trial results are expected to strengthen the marketing profile of Dupixent. Presently, the annual wholesale acquisition cost (or WAC) of Dupixent in the US is $37,000. To know more about Dupixent, please read, Dupixent May Prove Effective in Multiple Diseases.

Some conventional drugs used for atopic dermatitis include Bayer’s (BAYZF) Desonate, Valeant Pharmaceuticals’ (VRX) Elidel, and Pfizer’s (PFE) Eucrisa. The Health Care Select Sector SPDR Fund (XLV) invests ~0.91% of its total portfolio in Regeneron Pharmaceuticals.

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