EMA panel recommends nod for Sanofi, Regeneron's arthritis drug
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. (bit.ly/2p00FDy)
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.
More than 23 million people worldwide suffer from rheumatoid arthritis. Current treatments include the widely used methotrexate as well as non-steroidal anti-inflammatory drugs.
Other IL-6 inhibitors for rheumatoid arthritis include Roche Holding AG's approved Actemra and Johnson & Johnson's experimental sirukumab.
Last Friday, the FDA declined to approve a new rheumatoid arthritis drug, Olumiant, made by Eli Lilly and Co and partner Incyte Corp.
(Reporting by Rahul B in Bengaluru; Editing by Maju Samuel)
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. (bit.ly/2p00FDy)
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.
More than 23 million people worldwide suffer from rheumatoid arthritis. Current treatments include the widely used methotrexate as well as non-steroidal anti-inflammatory drugs.
Other IL-6 inhibitors for rheumatoid arthritis include Roche Holding AG's approved Actemra and Johnson & Johnson's experimental sirukumab.
Last Friday, the FDA declined to approve a new rheumatoid arthritis drug, Olumiant, made by Eli Lilly and Co and partner Incyte Corp.
(Reporting by Rahul B in Bengaluru; Editing by Maju Samuel)
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