Kevzara (sarilumab) has been approved in Canada as a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) who are either intolerant or considered inappropriate candidates to be treated with other anti-rheumatic drugs, according to Sanofi and Regeneron Pharmaceuticals.
“While there have been advances in the treatment of rheumatoid arthritis, not all available therapies work for every patient and there remains an unmet need for new therapeutic options,” David Meeker, MD, Sanofi Genzyme’s executive vice president, said in a news release. “The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA.”
Kevzara is an antibody that targets the interleukin-6 (IL-6) receptor, a protein that participates in several inflammatory reactions affecting the joints.
The approval was based on positive results obtained in several studies with nearly 2,900 adults with moderate to severely active RA who couldn’t be treated with other drugs. Kevzara was shown to improve RA symptoms and physical function, and to inhibit disease progression in nearly 1,743 patients, either when administered alone or in combination with other anti-rheumatic drugs, such as methotrexate.
“With Kevzara, we have a promising new therapy in Canada, which has shown clinically meaningful and statistically significant improvements in adult patients with moderately to severely active rheumatoid arthritis,” said William Bensen, professor of rheumatology at McMaster University in Ontario, Canada. “Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics.”
Kevzara is recommended to be administered in a subcutaneous injection of 200 mg every two weeks, but the dosage can be reduced to 150 mg to help manage laboratory anomalies. By the time the product will reach the market, there will be a support program to help patients have access to this treatment.
Treatment with this antibody is associated with a high risk of having serious and potentially life-threatening infections. Reported side effects in patients treated with Kevzara combined with other anti-rheumatoid drugs include neutropenia (low levels of a type of white blood cell, 6-10 percent of the patients); high levels of alanine aminotransferase (a marker of liver damage, 4-5 percent); erythema in the injection site (3-4 percent); and infections of the upper respiratory tract (3 percent).
Sarilumab hasn’t been approved in the U.S. due to anomalies identified during a routine good manufacturing practice inspection at the Sanofi Le Trait facility, where the drug is filled and finished. However, a new inspection will be carried out in 2017 and, according to the results, Sanofi plans to resubmit a regulatory license application to the U.S. Food and Drug Administration (FDA).
Sarilumab is also under evaluation in Europe and a decision from the European Medicines Agency is expected later this year.