FDA approves Sanofi and Regeneron’s Kevzara for adult rheumatoid arthritis
Sanofi and Regeneron Pharmaceuticals’ drug Kevzara (sarilumab) has received the US Food and Drug Administration (FDA) approval to treat adult patients affected with moderately to severely active rheumatoid arthritis (RA).
The drug has been approved for patients who exhibited an inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX).
RA is a chronic inflammatory autoimmune disease that affects the tissues of the joints, causing inflammation, pain and disability.
Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and inhibit IL-6R mediated signalling.
IL-6R is known to cause inflammation associated with RA in the long term.
Sanofi CEO Olivier Brandicourt said: “Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options.
“Today’s approval in the US not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology.”
The recommended dosage of Kevzara, which can be used as monotherapy or in combination, is 200mg once every two weeks as a subcutaneous injection.
The FDA approval of Kevzara was based on data collected from approximately 2,900 patients with moderately to severely active RA.
In two pivotal Phase III clinical trials, Kevzara with background DMARDs showed statistically significant improvements in those patients.
Sanofi and Regeneron have also introduced KevzaraConnect, a comprehensive and specialised programme to provide support services to patients during the treatment process.
The US Wholesale Acquisition Cost of Kevzara is $39,000 per year for 200mg and 150mg doses, while the actual cost may vary.
In the US, Kevzara will be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.
Last January, the drug was approved in Canada, while the European Commission is currently reviewing Kevzara for its commercialisation in the European Union.
The companies have also applied for approval in several other countries worldwide.