Regulatory Affairs

Sanofi, Regeneron secure EC approval for Kevzara to treat rheumatoid arthritis

PBR Staff Writer Published 28 June 2017

Sanofi and Regeneron Pharmaceuticals have secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.

The approval has been granted for Kevzara to treat moderately to severely active RA in adult patients who have responded inadequately or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs) such as MTX.

Kevzara is a human monoclonal antibody, which binds to the interleukin-6 receptor (IL-6R) and blocks pro-inflammatory IL-6 mediated signaling.

It can be used as monotherapy in case of intolerance to MTX or when treatment with methotrexate is inappropriate. 

Kevzara has been developed by using Regeneron's advanced VelocImmune technology, which enables to produce optimized fully-human antibodies.

The drug’s approval was based on recommendation of European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), which assessed results from seven phase 3 trials in the global SARIL-RA clinical development program.

The trials provided 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.

Kevzara, which already secured approval in the US and Canada, is also seeking approvals in multiple other countries across the globe.

Sanofi global R&D president Dr Elias Zerhouni said: "RA is a difficult-to-treat, lifelong disease and many healthcare providers are challenged with finding a treatment that works for their patients.

Regeneron president and chief scientific officer Dr George Yancopoulos said: "We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics such as TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals.”

Image: Head office of the European Commission. Photo: courtesy of Amio Cajander.