Market Just Got More Crowded as Regeneron, Sanofi's New RA Drug Wins FDA Approval

May 23, 2017
By Alex Keown, BioSpace.com Breaking News Staff

TARRYTOWN, N.Y. – Regeneron Pharmaceuticals and Sanofi have done it again. The two companies snagged approval from the U.S. Food and Drug Administration for the second time in two months. This time the companies received approval for its rheumatoid arthritis drug sarilumab, now dubbed Kevzara.

This morning, the companies said Kevzara was approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA, and levels of IL-6 correlate with both disease activity and joint destruction. Data from a Phase III trial released in March showed that sarilumab outperformed AbbVie’s Humira. Regeneron and Sanofi said its experimental sarilumab improved the signs and symptoms of rheumatoid arthritis (RA) patients after 24 weeks of use.

In March, the FDA approved Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis.

The second-time around proved to be the charm for Kevzara. In October, the FDA spurned the two companies due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Sanofi addressed the issue and the companies resubmitted the biologics application.

Rheumatoid arthritis is the most common form of autoimmune arthritis. It’s a painful affliction affecting the hands and joints, but there are numerous treatments, such as Genentech’s Rituxan or AbbVie’s Humira, that provide tremendous relief to patients. RA affects approximately 1.3 million Americans, the majority of which are women.

“Today's milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune," said George Yancopoulos, Regeneron’s chief scientific officer said in a statement.

Olivier Brandicourt, Sanofi’s chief executive officer, said that despite the “many advances” in RA treatment, patients continue to need new options.

But Kevzara will not come cheap. The drug will have an annual price of about $39,000 – but that’s long before reductions and insurance are factored into the actual retail price. The two companies though said that price is about 30 percent lower than the two most widely used TNF-alpha inhibitors. The average retail price of Humira is about $5,300.

Sarilumab is expected to generate $557 million in annual revenue by 2022, according to analysts’ projections. Kevzara was approved in Canada in January and is under consideration by the European Medicines Agency, where a decision is expected in the next few months.

Shares of Regeneron are up this morning, trading at $463.46 as of 10:14 a.m. Shares of Sanofi are also up, trading at $49.28 as of the same time.