Overcoming delay, Sanofi, Regeneron win US approval for RA drug
- Sanofi and Regeneron on Monday secured approval from the Food and Drug Administration for Kevzara (sarilumab), a treatment of rheumatoid arthritis co-developed by the French drugmaker and New York biotech, respectively.
- Kevzara will cost $39,000 per year for both the 200 mg and 150 mg doses — a list price which the two companies said represents a 30% discount to the wholesale acquisition cost of the two most commonly used anti-TNF alpha drugs, AbbVie's Humira (adalimumab) and Amgen's Enbrel (etanercept).
- Manufacturing issues at Sanofi's fill and finish facility in Le Trait, France led to an initial rejection of Kevzara last October, eventually delaying the drug's launch by nearly seven months. Kevzara is the third drug developed by the Sanofi/Regeneron partnership OK'd for use in the U.S., following closely on the heels of the recently approved Dupxient (dupilumab) in atopic dermatitis.
Sanofi, facing a tightening market for its diabetes medicines, hopes Dupixent and Kevzara will together anchor a leading immunology portfolio.
While Sanofi will essentially have to build the market around Dupixent in atopic dermatitis, Kevzara will be entering a rheumatoid arthritis market crowded with both top-selling blockbusters and newer entrants. TNF alpha inhibitors have dominated the therapeutic class for years: Humira, Enbrel and J&J's Remicade (infliximab) are all among the best-selling drugs in the world, with tens of billions in annual revenues between them.
Sanofi, however, sees market dynamics as shifting away from those mainstay drugs and the cycling between treatments that many patients go through before stabilizing. Kevzara, which targets the interleukin-6 receptor (IL-6), could help meet that opportunity.
"We think the IL-6 class and Kevzara specifically has a key role to play," said David Meeker, head of Sanofi Genzyme, on a April 28 earnings call.
Roche's Actemra (tocilizumab) also targets the IL-6 pathway, and Kevzara will face competition from Pfizer's newer JAK inhibitor Xeljanz (tofactinib).
In clinical trials, treatment with Kevzara on top of background methotrexate reduced signs and symptoms of rheumatoid arthritis, while also demonstrating improved physical function and less radiographic progression of structural damage, compared to placebo plus methotrexate.
A head-to-head study against Humira proved the superiority of Kevzara monotherapy among patients intolerant of methotrexate, although that data was not included in Kevzara's application package for regulator review.
The drug will carry a boxed warning for risk of serious infection, however, and treatment with Kevzara led to substantially higher rates of neutropenia compared to methotrexate and placebo.
For Regeneron, approval of both drugs validates the biotech's R&D chops and helps diversify revenues away from its flagship eye drug Eylea (aflibercept). While Sanofi and Regeneron's PCSK9 drug Praluent (alirocumab) has so far failed to live up to lofty expectations, the partnership between the two companies has been a fruitful one.
The partnership has shown a willingness to toe a softer line on pricing. Both Dupixent and Kevzara were priced lower than what perhaps might be expected for a novel drug. While neither can be considered "cheap" by any means, Sanofi and Regeneron seem to have learned a lesson from the struggles of Praluent, which ran into roadblocks from payers for its $14,000/year price tag. (A list price much higher than that of many generic statins.)
Regeneron and Sanofi will split profits and losses from sales of Dupixent and Kevzara in the U.S. In Europe, where the companies await final marketing authorization from the European Commission, the two will share profits based on a sliding scale.
- Sanofi Press release
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