Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) has received a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat adult patients with moderately to severely active rheumatoid arthritis (RA).
Kevzara is an investigational human monoclonal antibody acting against the IL-6 receptor.
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The CHMP has advised the use of Kevzara in combination with methotrexate (MTX) for RA patients who did not respond or intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Kevzara can also be administered as monotherapy in cases of intolerance to MTX or when treatment with MTX is inappropriate.
CHMP recommended that Kevzara should be administered in a 200mg dosage as a subcutaneous injection once every two weeks.
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The recommendation also prescribed that the dosage must be reduced to 150mg once every two weeks for the management of neutropenia, thrombocytopenia, and liver enzyme elevations.
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By GlobalDataFollowing this positive opinion from CHMP, Kevzara needs approval from the European Commission (EC) for marketing its product in the European Union.
EC is expected to provide its final decision on the Marketing Authorization Application (MAA) for Kevzara in the following months.
The CHMP provided its opinion on the basis of the results from seven Phase III trials in the global SARIL-RA clinical development programme, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH.
These studies procured data from more than 3,300 adults affected with moderate-to-severe active RA who did not respond adequately or intolerant to one or more biologic or non-biologic DMARDs.
In Europe, approximately 2.9 million people suffer from RA that makes everyday life difficult, causing joint pain, swelling, stiffness and fatigue.
Kevzara is already approved in Canada and is currently under review in the US.
The companies have also planned to secure approval in other countries worldwide.
