Sanofi & Regeneron’s arthritis drug scores first approval following FDA rejection

pharmafile | February 1, 2017 | News story | Research and Development, Sales and Marketing Actemra, Humira, Kevzara, Regeneron, Roche, Sanofi, sarilumab 

Kevzara (sarilumab), a interleukin-6 (IL06) receptor antibody developed by Sanofi and Regeneron and the first real competitor to Roche’s Actemra (tocilizumab), has been awarded its first marketing approval by Health Canada for use in the country for the treatment of moderate to severe rheumatoid arthritis (RA) in adult patients who have proved intolerant or non-responsive to biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

The drug was originally knocked back by the US Food and Drugs Administration (FDA) in October last year over concerns raised around “certain deficiencies” apparent at a Sanofi manufacturing facility in Normandy, France where sarilumab is finished. With the first approval of the drug, Sanofi has stated its intention to apply for approval with the FDA once again in the first quarter of this year, with an EU submission to follow soon after.

Canada Health accepted the submission on the basis of a global 2,900-participant trial in which RA sufferers were treated with Kevzara either as monotherapy or as a combination treatment with other DMARDs such as methotrexate. The drug showed “clinically-meaningful improvements” in reducing symptoms of the disease, inhibiting radiographic progression of structural damage and improving physical function in 66% of patients.

Despite these positive results, it was noted that those treated with the drug are “at increased risk for developing serious infections that may lead to hospitalization or death”.

The approval could mean the start of something big for Sanofi and Regeneron after Kevzara showed in trials that it was more effective than the world’s best-selling drug Humira. With analysts expecting the drug to bring in sales of between $500 million and $1 billion by 2020, it could muscle into the $1.7 billion revenue generated by rival Actemra in 2016.

“While there have been advances in the treatment of rheumatoid arthritis, not all available therapies work for every patient and there remains an unmet need for new therapeutic options,” commented David Meeker, Executive Vice President and Head of Sanofi Genzyme. “The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA.”

Dr William Bensen, Clinical Professor of Rheumatology, Department of Medicine at McMaster University in Ontario, Canada added: “With Kevzara, we have a promising new therapy in Canada, which has shown clinically-meaningful and statistically significant improvements in adult patients with moderately to severely active rheumatoid arthritis. Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics.”

Kevzara will be available to Canadian patients “soon”, according to the companies.

Matt Fellows

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