Sanofi and Regeneron Pharmaceuticals have announced the FDA’s approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
FDA approval
“In the clinical trial programme, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms, improving physical function, and resulting in significantly less radiographic progression of structural damage of RA,” said Dr Alan Kivitz, CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, and an investigator in the global SARIL-RA clinical programme for sarilumab. “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. Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”
RA is a chronic inflammatory autoimmune disease where the tissues of the joints are attacked, causing inflammation, pain and damage to the joints. Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) — a cytokine that, in excess and over time, can contribute to inflammation associated with RA.
“Despite the many advances made in the treatment of RA, patients continue to need new treatment options,” added Dr Oliver Brandicourt, chief executive officer, Sanofi. “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 approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active RA who had inadequate response to previous treatment regimens. Two Phase III trials, the MOBILITY and TARGET studies, demonstrated that Kevzara with background DMARDs offer statistically significant, clinically-meaningful improvements in patients affected by moderate to severe RA.
Kavzara may be used as monotherapy or in combination with other conventional DMARDs and has been recommended at a dose of 200 mg once every two weeks, to be administered as a sub-cutaneous injection.