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Regeneron, Sanofi’s Kevzara becomes first biologic approved for polymyalgia rheumatica

After a brief appearance in the pandemic fight, Regeneron and Sanofi’s Kevzara is back with a new indication.

Late Tuesday, the partners said the drug scored an FDA approval to treat polymyalgia rheumatica in adult patients who can’t taper or don’t respond to corticosteroid treatment. 

With the approval, Kevzara becomes the first biologic drug approved to treat polymyalgia rheumatica. 

Polymyalgia rheumatica often causes pain and stiffness in patients’ necks, shoulders and hips, according to the companies. Patients often experience trouble with everyday motions such as standing from a chair or raising their arms.

The inflammatory disorder is primarily treated with corticosteroids, leaving patients who can’t taper at increased risk of complications stemming from long-term steroid use, Regeneron’s chief scientific officer, George Yancopoulos, said in a company statement.

Kevzara won its original FDA nod in 2017 to treat moderate to severe rheumatoid arthritis in certain patients.

During the pandemic, researchers studied Kevzara and other IL-6 inhibitors against COVID-19. The drug turned in mixed results and Sanofi and Regeneron eventually nixed the research.

But in one study in the U.K., the drug significantly reduced the risk of death in hospitalized COVID-19 patients.

In polymyalgia rheumatica, the FDA based the approval on results from a phase 3 trial. In the study, 28% of Kevzara-treated patients reached sustained remission, compared with 10% in the placebo group.

Outside of Kevzara, Regeneron is preparing for a June FDA decision date for a high-dose version of superstar Eylea, while Sanofi is busy working on its Altuviiio launch in hemophilia A.