Dupixent Expected to Become a Leading Therapy for Atopic Dermatitis
Dupixent in atopic dermatitis
In March 2017, Regeneron (REGN) and Sanofi’s (SNY) interleukin-4 and interleukin-13 blocker, Dupixent, secured its first regulatory approval from the FDA as a treatment option for adults with moderate-to-severe atopic dermatitis (or AD) who either did not respond sufficiently to topical therapies or for whom such therapies are not appropriate.
On July 21, 2017, the European Medicines Agency’s (or EMA) Committee for Medicinal Products for Human Use (or CHMP) granted a positive opinion to Dupixent as a treatment option for adult AD patients eligible for systemic therapy. The drug is expected to be approved in the European Union in 3Q17.
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In addition to adult AD indication, Regeneron and Sanofi are also evaluating the potential of Dupixent in pediatric AD indication. The companies are currently enrolling AD patients in the age group of 12–17 years in the Phase 3 trial.
Further, Regeneron and Sanofi plan to initiate two studies to study the efficacy of Dupixent in younger patients, in the age group of six years to 11 years and six months to five years, respectively.
In addition to AD, this IL-4/IL-13 inhibitor is also expected to demonstrate strong efficacy in multiple atopic or allergic conditions. If this expectation proves correct, it may have a favorable impact on Regeneron’s stock price and the iShares Core S&P 500 ETF (IVV). Regeneron makes up ~0.17% of IVV’s total portfolio holdings.
In 2Q17, the drug reported sales of $29 million on a global basis. This was mainly driven by demand in the US and did not include much of a contribution from inventory buildup.
To rapidly reach out to the 300,000 AD patients in the US, Regeneron and Sanofi have focused their attention on creating awareness for Dupixent among the dermatologists who have experience of prescribing biologics, allergists, and immunologists, as well as 7,000 doctors in the country.
Since its launch, Dupixent has witnessed growth in prescriptions at a rate faster than that seen for other newly launched dermatology drugs. By July 26, 2017, the drug was already prescribed by 5,100 healthcare providers while prescriptions were written for ~13,000 patients.
In the next article, we will discuss key growth drivers of Dupixent in greater detail.