A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis.
The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, Kevzara, citing its ability to reduce the signs and symptoms of rheumatoid arthritis.
Sarilumab, the active substance of Kevzara, a treatment for adult patients with moderate to severe rheumatoid arthritis, works by blocking a protein called IL-6, which is associated with inflammation.
The panel’s opinion will now be reviewed by the EMA.
In October, U.S. regulators declined to approve sarilumab because of manufacturing deficiencies at a Sanofi plant in France.
Regeneron said in February that it was planning to resubmit a marketing application to the U.S. Food and Drug Administration for sarilumab.
The drug has already been approved by Canadian health regulators to treat rheumatoid arthritis.
Eben Britton is a man who understands pain. Within his six-year NFL playing career as an offensive lineman for the Jacksonville Jaguars and Chicago Bears, he experienced major and minor injuries alike, including a torn labrum, a hamstring injury, a herniated disc resulting in sciatica that still ails him to this day. “I can’t feel my right foot on the ground,” he tells me.
Compounding these injuries is the game of football itself, America’s most bone-crushing sport. The crunching tackles and successful blows devastate the body over time. How football addles the brain is a topic the league would prefer not to discuss. “It’s a violent game that I personally don’t think humans are supposed to play,” said Doug Whaley, the Buffalo Bill general manager, last year.