Aims to balance affordability and rewarding innovation with the treatment's pricing
Regeneron and partner Sanofi have US approval for one of the most highly-anticipated drugs in their pipeline, Dupixent for moderate-to-severe atopic dermatitis or eczema.
Dupixent (dupilumab) - an interleukin-4 (IL-4) and IL-13 inhibitor - has been approved for atopic dermatitis patients who do not respond to or should not use topical prescription therapies, and according to Regeneron CEO Leonard Schleifer "will change the way doctors are able to treat their moderate to severe atopic dermatitis patients".
Sanofi and Regeneron maintain that there is a huge unmet medical need among patients at the upper end of the symptoms spectrum, with around 1.6 million people out of 18-25 million people with the disease in the US with symptoms that are uncontrolled on current therapies.
The companies have set the annual price of their drug at around $37,000 per patient per year – which they said walked the line between affordability and reward for innovation – although it comes in above the $30,000-to-$35,000 range expected by analysts at Leerink.
A spokesman for pharmacy benefit manager Express Scripts seemed to be happy with the list price, telling the Wall Street Journal it was "responsible", while a draft evidence report from the non-profit Institute for Clinical and Economic Review (ICER) suggests that at a $30,000 annual price - which could be reached with discounting - would bring it into the range of cost-effectiveness versus existing drugs.
The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of nearly 2,200 adults, according to the FDA which said that overall participants who received the drug achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.
"Eczema can cause significant skin irritation and discomfort for patients so it is important to have a variety of treatment options available to patients," commented Julie Beitz, who heads the Office of Drug Evaluation III at the agency's Center for Drug Evaluation and Research (CDER).
Dupixent's approval comes just a few weeks after Pfizer won a green light from the regulator for Eucrisa (crisaborole) for patients with milder forms of atopic dermatitis - which the company believes could become a $2bn-a-year product as it allows patients to avoid using corticosteroids, which can have serious side effects with chronic use.
Analysts have even greater expectations for Regeneron and Sanofi's new drug - predicting $2.8bn in sales as the drug will avoid not only steroids but also much more potent drugs like cyclosporine and methotrexate, which have significant toxicities that prevent long-term use.
Sanofi and Regeneron also have a fairly clear run at the market for the foreseeable future. Roche and AstraZeneca are also developing antibody-based drugs for atopic dermatitis, but their drugs - nemolizumab and tralokinumab respectively - are still in mid-stage testing.
Dupilumab is also under regulatory review in the EU, with the European Medicines Agency (EMA) kicking off its appraisal of the drug last December.