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FDA Panel Rejects J&J RA Drug

Walter Eisner • Fri, August 4th, 2017

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The FDA’s Arthritis Advisory Committee voted 12-1 on August 2, 2017 to deny approval for Johnson & Johnson's rheumatoid arthritis (RA) drug, Plivensia (sirukumab).

The drug works by blocking a cytokine in the body known as interleukin 6 (IL-6) that can contribute to the inflammation associated with rheumatoid arthritis.

The company was seeking BLA (Biologics License Application) approval for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The drug would join a market that includes, Humira, Actemra and Kevzara among others, though its once-monthly dosing schedule could give it an advantage.

Rheumatoid Arthritis and Ortho

Aching joints are common in arthritis. According to the AAOS (American Academy of Orthopaedic Surgeons), in RA the joint lining swells, invades surrounding tissues, and produces chemical substances that attack and destroy the joint surface. People of all ages may be affected. The disease usually begins in middle age and affects about 1.3 million people in the U.S.

Rheumatoid arthritis usually affects joints on both sides of the body in the hands and feet, as well as the hips, knees, and elbows. Without proper treatment, rheumatoid arthritis can become a chronic, disabling condition.

The disease is diagnosed using a medical history and a physical examination. Some of the conditions the doctor looks for include swelling and warmth around the joint, painful motion, lumps under the skin, joint deformities, and joint contractures (inability to fully stretch or bend the joint).

A blood test may reveal an antibody called rheumatoid factor. This is an indicator of RA. X-rays can help show the progression of the disease.


AAOS says medications used to control RA fall into two categories: those that relieve symptoms and those that have the potential to modify the course of the disease. Often, they are used together. Aspirin and ibuprofen can help reduce the pain and inflammation of RA. Disease-modifying drugs include methotrexate and sulfasalazine and gold injections.

Biologic agents also can interrupt the progress of the disease. These agents target specific chemicals in the body to prevent them from acting on the joints.

Safety Concerns

Prior to the advisory committee meeting, FDA staff had released briefing documents for the meeting which indicated a lot of emphasis would be placed on the safety profile of the drug especially the imbalance in all cause death between Plivensia and placebo.

Sure enough, committee members reportedly cited safety concerns, including an imbalance in the number of deaths in patients taking sirukumab compared with those taking a placebo. The most common causes of death were major heart problems, infection and malignancies.

"The safety is not there," said Beth Jonas, M.D., interim head of the division of rheumatology at the University of North Carolina School of Medicine.

Reuters reported that panelists said they were especially reluctant to recommend approval of sirukumab because there are two other drugs on the market in the same class mentioned above. Maria Suarez-Almazor, M.D., rheumatology section chief at the University of Texas MD Anderson Cancer Center, said, "If this was a new agent I would probably be a little more enthusiastic. There is no reason to think that this new drug will act in a tremendously different way."

This is only a recommendation from the advisory committee. The agency is free to accept the recommendation, ask the company for more information, or approve the BLA.

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