Sanofi, Regeneron's Dupixent garners FDA approval for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals announced Tuesday that the FDA approved Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. The companies noted that the drug, which will have an annual wholesale acquisition cost of $37 000, is the first biologic medicine cleared for the condition. 

The approval was supported by safety and efficacy data from the LIBERTY AD clinical programme consisting of three late-stage studies involving a total of 2119 adults. Results from the LIBERTY AD SOLO 1 and SOLO 2 trials, which were unveiled in April last year, showed that Dupixent significantly improved several measures, including overall disease severity, skin clearance and quality of life, versus placebo. Meanwhile, in the LIBERTY AD CHRONOS study, in which patients were treated with Dupixent or placebo, both in combination with topical corticosteroids, Sanofi and Regeneron's drug significantly improved measures of overall disease severity compared to placebo.

Sanofi CEO Olivier Brandicourt commented "the approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally." Sanofi and Regeneron plan to launch the subcutaneous therapy, which is designed to inhibit IL-4 and IL-13, in the US later this week.

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Regarding pricing, Sanofi Genzyme chief executive David Meeker acknowledged "it won't be the cheapest drug," adding "we've had very constructive conversations with payers as we try to find that balance." Meanwhile, Express Scripts chief medical officer Steve Miller contended "this is really a great example of how it should work." For related analysis, read ViewPoints: Regeneron, Sanofi look to 'goldilocks' pricing strategy for Dupixent). 

Miller added "our plans would obviously like a lower price, continuing "[Regeneron's] shareholders would like a higher price. I think the fact we disappointed everyone probably means this came in where it should have." Express Scripts additionally reportedly elected to not restrict coverage of the drug based on the percent affected body area.

RBC Capital Markets analysts noted that the list price of $37 000 a year exceeded their expectations of $20 000 to $30 000, while other pharmacy benefit managers have yet to clarify whether they will cover the drug." CVS Caremark stated "as we prepare for the approval of this medication, we are developing programmes for our clients to ensure this new therapy is available for those patients with a demonstrated medical need for the drug, based on its indications as approved by the FDA." 

Baird Equity Research's Brian Skorney said that analysts anticipate sales of $200 million for Dupixent this year, which would exceed the first-quarter sales of drugs such as AbbVie's Humira (adalimumab) and Amgen's Enbrel (etanercept). Meanwhile, some analysts have forecast peak annual sales for Dupixent of as much as $5 billion. 

Dupixent was previously awarded priority review and breakthrough therapy designation by the FDA for the treatment of moderate-to-severe atopic dermatitis. The European Medicines Agency accepted Sanofi and Regeneron's submission of Dupixent for review for the treatment of atopic dermatitis in December last year. 

For related analysis, see ViewPoints: KOLs encouraged by Regeneron, Sanofi's dupilumab for treatment of severe asthma. See also ViewPoints: Amgen may be exploring IL-4R IP dispute – damages, bargaining chip or much ado about nothing?

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