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EMA's CHMP recommends approval for Kevzara for rheumatoid arthritis

Published 25 April 2017

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.

Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor.

Elias Zerhouni, M.D., President, Global R&D, Sanofi said: “Rheumatoid arthritis is a painful and debilitating disease which impacts millions of people in Europe, many of whom are still struggling to find a treatment that works for them.

“We welcome today’s positive CHMP opinion for Kevzara, which brings us one step closer to making this new treatment option available to patients in Europe.”

The CHMP recommended the use of Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

The recommended dose of Kevzara is 200 mg once every two weeks administered as a subcutaneous injection. Reduction of dose from 200 mg once every two weeks to 150 mg once every two weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.

The European Commission (EC) is expected to make a final decision on the Marketing Authorization Application (MAA) for Kevzara in the European Union in the coming months. The CHMP opinion is based on results from seven Phase 3 trials in the global SARIL-RA clinical development program, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH.

These studies incorporate data from more than 3,300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

In Europe, 2.9 million people suffer from RA, and living with the disease can make everyday life difficult.

Symptoms include joint pain, swelling, stiffness, and fatigue.

In Canada, Kevzara is approved for use in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

Sarilumab is currently under review in the United States, and the companies are also seeking approvals in a number of other countries globally.



Source: Company Press Release