Sanofi and Regeneron score FDA approval for arthritis
pharmafile | May 23, 2017 | News story | Manufacturing and Production, Sales and Marketing | FDA, Kevzara, arthritis, sarilumab
The FDA has awarded Sanofi and Regeneron’s Kevzara (sarilumab) approval for the treatment of moderate to severely active rheumatoid arthritis (RA) in patients who have not responded to prior therapy.
Kevzara is co-developed by Sanofi Genzyme and Regeneron; both will split revenue from sales of the drug. The drug was originally knocked back by the FDA in October due to ‘deficiencies’ in its manufacturing process at a company facility in Normandy, France. These issues have since been rectified.
Kevzara is available as a single treatment or as a combination therapy. It operates by blocking the activation of cell receptors which cause inflammation in the joints and lead to the manifestation of symptoms observed in RA.
It enters the $20 billion RA market with the hope of biting into the shares of the area’s multiple contenders. The drug has shown its ability, through a number of clinical studies, to outclass market-leader Humira in those who did not respond well to methotrexate as a first-line treatment.
“We have very high hopes for Kevzara,” said Jonathan Sadeh, Vice President, Immunology and Inflammation at Sanofi as well as Clinical Research Lead for the drug programme. “It fills an important unmet need.” In tests of the experimental drug on rheumatoid arthritis patients, he said, “we’ve shown a clinically meaningful impact on symptoms and on slowing down the progression of the disease.”
“It’s important to give clinicians more options in treating this disease,” he added. “If you have an inadequate response to one mechanism, it’s better to go to another mechanism.”
Matt Fellows
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