FDA approves Regeneron drug Kevzara for rheumatoid arthritis

The U.S. Food and Drug Administration has approved the human antibody drug sarilumab, developed by Regeneron Pharmaceuticals Inc. in Westchester and its French pharmaceutical partner Sanofi and trademarked as Kevzara, to treat adult patients with moderately to severely active rheumatoid arthritis who do not adequately respond to or tolerate antirheumatic drugs, the companies jointly announced on Monday. The drug is taken by injection every two weeks.

The FDA approval came less than two months after the federal agency approved Regeneron”™s and Sanofi”™s human antibody dupilumab, marketed as Dupixent, as the first biologic medicine used to treat the debilitating itching and widespread rashes afflicting adults with moderate to severe cases of atopic dermatitis.

Alan Kivitz, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center and an investigator in the global clinical program for sarilumab, in the announcement called Kevzara “a welcome new option for patients and their physicians” in treating rheumatoid arthritis or RA, a chronic inflammatory autoimmune disease in which the immune system attacks the tissues of the joints, causing inflammation, pain and eventually joint damage and disability. It affects approximately 1.3 million Americans, of whom nearly 75 percent are women.

Kivitz said the drug, in clinical trials that involved about 2,900 patients, reduced signs and symptoms of the chronic disease and improved physical function, “resulting in significantly less radiographic progression of structural damage of RA. This is important because not all currently available treatments work in all patients and some patients may spend years cycling through different treatments without achieving their treatment goals.”

ndmark at Eastview campus, George D. Yancopoulos, the company”™s founding scientist, president and chief scientific officer, said the FDA approval of Dupixent and Kevzara in close succession “showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune.” Regeneron”™s proprietary technology platform uses specially bred mice to generate and discover fully human antibodies as potential treatments for a range of diseases.

Yancopoulos said the FDA milestone for Kevzara “would not have been possible without our important ongoing collaboration with Sanofi, and most importantly, the patients and physicians who participated” in the clinical trials.

The listed acquisition cost of Kevzara for U.S. wholesalers is $39,000 a year for 200 mg and 150 mg doses. That is approximately 30 percent lower than the wholesale acquisition costs for the two most widely used anti-inflammatory drugs, according to Regeneron and Sanofi. Actual costs to patients, insurance payers and health systems are expected to be lower after discounts, rebates and other adjustments are applied.

Sanofi and Regeneron have launched KevzaraConnect, a support services program for patients receiving the new treatment that will also help eligible patients who are uninsured, lack coverage or need assistance with their out-of-pocket copay costs.  KevzaraConnect also offers around-the-clock personalized support from registered nurses and other specialists available to help patients navigate the insurance process.

Kevzara will be marketed in the U.S. by Regeneron and Sanofi Genzyme. The drug was approved in Canada in January and a European Medicine Agency committee in April recommended Kevzara”™s approval for use in adult patients with moderately to severely active RA. The companies said a final marketing authorization in the European Union will be decided by the European Commission in the coming months.

The companies said they are also seeking approvals to market Kevzara in a number of other countries.