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Sanofi Genzyme's Kendall Square site.

Federal regulators Monday OKd a drug made by Cambridge-based Sanofi Genzyme to treat rheumatoid arthritis, a painful condition that affects millions of people worldwide, including more than 1.3 million in the United States.

The regulatory sign-off on Kevzara, co-developed with Regeneron Pharmaceuticals Inc. of Tarrytown, NY, marked the second major US drug approval this year for Sanofi Genzyme, the specialty care arm of French drug giant Sanofi SA. In late March, the Food and Drug Administration gave a green light to the companys medicine to treat severe forms of eczema.

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The FDA approved Kevzara for adult patients with moderately to severely active rheumatoid arthritis who have not responded adequately to other treatments. Doctors can prescribe Kevzara as a sole treatment or in combination with other medicines. The drugs label will include a safety notice that it can cause side effects, including serious infections, in some patients.

We have very high hopes for Kevzara, said Jonathan Sadeh, a Sanofi vice president and clinical research lead for the drug program. It fills an important unmet need. In tests of the experimental drug on rheumatoid arthritis patients, he said, weve shown a clinically meaningful impact on symptoms and on slowing down the progression of the disease.

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Mondays approval came seven months after the FDA delayed a decision on the rheumatoid arthritis treatment, citing deficiencies found during inspection of a Sanofi manufacturing site in Normandy, France. The problems have since been addressed.

The drug was approved by Canadian regulators in January, and Sanofi Genzyme and Regeneron which will split the revenues are awaiting decisions in Europe and Japan by the end of the year.

Unlike the eczema drug Dupixent, which biopharma analysts have pegged as a blockbuster product with peak sales topping $1 billion a year, Kevzara will enter a market crowded with existing medicines that work in different ways. The top-selling rheumatoid arthritis treatment is Humira, sold by North Chicago, Ill., biopharma AbbVie Inc.

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But the global rheumatoid arthritis market has been estimated at $20 billion, and its been growing at about 2 percent a year. That means Kevzara could generate significant revenue if it can make inroads into the market.

In more than a half dozen late-stage clinical trials, Kevzara outperformed Humira in improving the condition of patients who didnt respond well to a common first-line treatment called methotrexate. Its important to give clinicians more options in treating this disease, Sadeh said. If you have an inadequate response to one mechanism, its better to go to another mechanism.

Kevzara is a type of biologic drug known as a monoclonal antibody. It works by blocking the activation of cell receptors that cause inflammation of joints throughout the body. Sadeh said the same type of action could potentially treat many other diseases.

Scientists at Sanofi Genzyme and Regeneron, who are collaborating in a broad drug development alliance, are actively reviewing other indications, Sadeh said.

In addition to Kevzara, the collaboration already has yielded two other approved drugs. One is Dupixent; the other is Praulent, which treats hypercholesterolemia, a condition that affects people with extremely high levels of cholesterol.

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FDA approves Sanofi Genzyme rheumatoid arthritis drug - The Boston Globe

This entry was posted on May 23, 2017 at 7:41 am and is filed under Arthritis. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |