The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara, Sanofi/Regeneron) for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who do not respond well to or have intolerance to disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, according to a new release from the manufacturers.
Late last year, as reported by Medscape Medical News, the FDA declined to approve sarilumab because of manufacturing problems at a Sanofi plant in France. At that time, Sanofi said it was correcting the problems. The companies said the FDA did not cite any safety concerns in its notice.
Sarilumab was approved in Canada in January and was backed for marketing in the European Union by the European Medicines Agency’s Committee for Medicinal Products for Human Use last month.
“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,” Alan Kivitz, MD, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Pennsylvania, who was an investigator in the global trial for sarilumab, said in the news release.
He noted that patients with RA often try multiple treatments that are currently available without relief of symptoms. RA affects approximately 1.3 million in the United States, of whom nearly 75% are women.
Sarilumab is a monoclonal antibody that binds to the interleukin-6 receptor, a cytokine associated with inflammation. It can be used alone or in combination with methotrexate or another DMARD.
The drug will be marketed as a self-injectable solution in prefilled syringes and pens given in 200-mg doses once every 2 weeks.
According to the companies, the dose can be reduced to 150 mg once every 2 weeks to help manage complications of neutropenia, thrombocytopenia, and elevated liver enzyme levels.
Sarilumab’s approval comes after two phase 3 trials involving about 2900 adults whose condition did not respond well to existing treatments and who showed positive results with the drug.
Along with neutropenia and elevated liver enzyme levels, other common adverse reactions were injection site erythema, upper respiratory infections, and urinary tract infections.
The list price for sarilumab will be $39,000/year for both the 200-mg and 150-mg doses, but that is 30% lower than the list price for its two main rivals, according to the companies.
Help with navigating insurance options is available at www.Kevzara.com.
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