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FDA Approves Kevzara for Rheumatoid Arthritis
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After a resubmission by Sanofi and Regeneron Pharmaceuticals Inc., the FDA has approved Kevzara for the treatment of patients with rheumatoid arthritis, according to a company press release.
“Sarilumab [(Kevzara, Sanofi and Regeneron Pharmaceuticals Inc.)] works differently from the most commonly used biologics, such as those in the anti-[tumor necrosis factor] TNF class, and is a welcome new option for patients and their physicians,” Alan Kivitz, MD, investigator in the global clinical program for Kevzara, said in the release.
Kevzara — a human monoclonal antibody that inhibits interleukin-6R signaling and has already been approved in Canada — has been approved as monotherapy or in combination with methotrexate or other conventional disease-modifying antirheumatic drugs (DMARDs) for adults with moderate to severely active rheumatoid arthritis (RA) and who have had an inadequate response or intolerance to methotrexate or other DMARDs. According to the release, the recommended dose — which can be self-administered — is 200 mg given subcutaneously once every 2 weeks. To help manage laboratory abnormalities, such as neutropenia, thrombocytopenia and liver enzyme elevations, the dose can be reduced to 150 mg.
For the approval, the FDA examined data from two phase 3 trials of 2,900 adult patients with RA. According to the release, the first study showed a significant improvement in ACR20 response at 24 weeks (66% for 200 mg, 58% for 150 mg and 33% for placebo), a significant decrease in radiographic progression of structural damage according to modified total sharp score at 52 weeks (0.25 for 200 mg, 0.9 for 150 mg and 2.78 for placebo) and a significant improvement from baseline in physical function according to the health assessment questionnaire disability index (HAQ-DI) (–0.58 for 200 mg, –0.54 for 150 mg and –0.3 for placebo). The second study also showed a significant improvement in ACR20 response at 24 weeks (61% for 200 mg, 56% for 150 mg and 34% for placebo) as well as a significant improvement in physical function according to HAQ-DI at 12 weeks (–0.49 for 200 mg, –0.5 for 150 mg and –0.29 for placebo).
As for safety, the release noted that patients treated with Kevzara had an increased risk for serious infection and the most common adverse events were neutropenia (between 7% and 10% for Kevzara vs. 0.2% for placebo), increased alanine aminotransferase (5% for Kevzara vs. 2% for placebo), injection site erythema (between 4% and 5% vs. 0.9%), upper respiratory infection (between 3% and 4% vs. 2%) and urinary tract infection (3% vs. 2%).
For pricing, the U.S. wholesale acquisition cost is $39,000 per year, which is about 30% lower than the two most-commonly used TNF-alpha inhibitors, according to the release.
In addition, Kevzara has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use and a decision is expected in the coming months regarding its approval in Europe, the release noted.
“[The] approval in the [United States] U.S. 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,” Olivier Brandicourt, MD, chief executive officer of Sanofi, said in the release.
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