FDA OKs Eczema Injection; Owners Regeneron, Sanofi Set $37K Price

Xconomy New York — 

For the more severe cases of eczema—inflamed skin that can range from annoying dry patches to painful swelling, oozing, and cracking—there’s a new injectable medicine on the market that will cost tens of thousands of dollars a year. The FDA approved today dupliumab (Dupixent) for adults whose condition cannot be controlled with topical creams.

The drug’s owners, Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NYSE: SNY), have announced a list price of $37,000 a year, which is likely to be whittled down through negotiations with insurance companies and their agents.

The drug is specifically for atopic dermatitis, which falls under the broader category of eczema. For a condition usually managed with readily available creams and steroids, a big question is whether patients and doctors will opt for a pricey self-administered injection every other week. Analysts noted today that Sanofi management has flagged the “the lack of experience with biologics in atopic dermatitis” as a reason for caution.

An even bigger question is whether insurers will pay for it. An influential evaluator has begun investigating the relative value of dupilumab and another new eczema drug, crisaborole (Eucrisa) from Pfizer (NYSE: PFE), which is applied topically. The evaluator, known by the acronym ICER, released a draft report last week which acknowledged the need for new therapies: “Patients with moderate-to-severe disease experience substantial disruptions to their lives with the disorder disturbing sleep and affecting all aspects of social functioning. In this landscape of a routinely undertreated disease with substantial burdens, more acceptable and effective therapies are clearly needed.”

Regeneron and Sanofi have already gotten burned in the U.S. fight over drug prices. Their cholesterol lowering drug alirocumab (Praluent) launched last year with better marks at lowering cholesterol than the current standard of care, called statins. Yet the $14,000 annual list price, plus unanswered questions about the drug’s ability to reduce heart attacks and strokes, have choked off sales of alirocumab as well as a rival cholesterol drug from Amgen.

The partners are also testing dupilumab in a large study for asthma. The results should be ready later this year.

The $37,000 list price for dupilumab announced today was slightly higher than some analysts expected. Geoffrey Porges of Leerink wrote in a research note Tuesday that he expected an annual list price for of $30,000 to $35,000, based on ICER’s draft assessments, as well as the public position of Regeneron CEO Leonard Schleifer, who has been vocal about the arrogance of his peers in setting high prices.

Porges wrote that the “low end of the range for injectable treatments for psoriasis”—another autoimmune skin condition that is treated with injectable drugs—“provide the most sensible template” for dupilumab.

The FDA put the approval process on a fast track last fall after Regeneron, of Tarrytown, NY, and Paris-based Sanofi reported data from three Phase 3 studies, totaling more than 2,100 patients.

In announcing the approval, the FDA also flagged side effects including oral cold sores, serious allergic reactions, and eye problems such as pink eye and cornea inflammation.

Photo by Oregon State University via a Creative Commons 2.0 license.