Pharma Focus Asia

Regeneron and Sanofi Receive Positive CHMP Opinion for Kevzara® (sarilumab)

Monday, April 24, 2017

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Kevzara® (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis. Kevzara is an investigational human monoclonal antibody directed against the IL-6 receptor.

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 also be given as monotherapy in cases of intolerance to MTX or when treatment with MTX is inappropriate.1 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. 2,3 Symptoms include joint pain, swelling, stiffness, and fatigue.4

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.

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