Kevzara Takes Step Toward EU Approval, While FDA Decision Is Expected in May

Kevzara Takes Step Toward EU Approval, While FDA Decision Is Expected in May

Kevzara (sarilumab) has received a thumbs-up from the European Medicine Agency (EMA), which has recommended that the European Commission approve it to treat adults with moderate to severe rheumatoid arthritis, according to a press release.

Meanwhile, the Food and Drug Administration is expected to make a decision by May 22 on whether to approve Kevzara’s use in the United States,  according to another press release. The therapy’s developers are Regeneron and Sanofi.

The EMA’s Committee for Medicinal Products for Human Use recommended Kevzara as a treatment for patients who have failed to respond to at least one other disease-modifying anti-rheumatic drug.

Kevzara is intended to be used in combination with methotrexate. But the EMA committee recommended that the drug be able to be used alone when patients can’t tolerate methotrexate, or if the combo treatment is inappropriate.

The committee endorsed an injected dose of 200 mg once every two weeks. If a patient experiences side effects, such as  elevated liver enzymes or low platelet and neutrophil counts, the dose can be lowered to 150 mg once every two weeks, it 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,” Dr. Elias Zerhouni, president of global research and development at Sanofi, said in a press release.

“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,” Zerhouni added.

Regeneron and Sanofi submitted a Biologics License Application for Kevzara to the FDA on January 16, 2016. There was supposed to be a verdict in October of last year, but the process was placed on hold when the FDA discovered manufacturing irregularities at a French facility that processed Kevzara and other drugs.

The companies resubmitted the application — a signal that the irregularities in the French facility have been dealt with.

Kevzara is an antibody that targets the cytokine IL-6 (interleukin-6) protein that is believed to play an important role in rheumatoid arthritis.

The marketing approval applications the developers submitted in both Europe and the United States were based on data from seven Phase 3 clinical trials. The studies, going under the name SARIL-RA, included more than 3,300 adults. Patients consistently benefitted from the treatment.

Kevzara was approved in Canada in February 2017.

 

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