FDA Approves Kevzara for Inflammatory Rheumatic Disease

The FDA has approved Kevzara (sarilumab) to treat adult patients with polymyalgia rheumatica (PMR), an inflammatory rheumatic disease. It is indicated for patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

PMR often initially presents with pain and stiffness around the neck, shoulder, and hip area and symptoms include fatigue, low-grade fever, and weight loss. Patients often experience flares during tapering of, or relapse after discontinuation of corticosteroid treatment. PMR generally affects people who are 50 years and older.

Developed by Regeneron and Sanofi, Kevzara is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy. Kevzara binds specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis.

Kevzara has an average retail price of $5,554.56 for one carton of two syringes, according to GoodRx. Patients with commercial insurance can apply for $0 copay, up to an annual maximum of $15,000, through the KevzaraConnect program. The company also offer a free, one-time 30-day supply, as well as a patient assistance program for uninsured and underinsured.

George D. Yancopolous, M.D., Ph.D.

“Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy,” George D. Yancopolous, M.D., Ph.D., president and chief scientific officer at Regeneron, said in a press release.

The approval is based on phase 3 data demonstrating almost three times more patients treated with Kevzara achieved sustained remission compared with placebo. In the SAPHRY trial, patients were randomized to receive either Kevzara 200 mg every two weeks along with a 14-week taper of corticosteroids or placebo every two weeks along with a 52-week corticosteroids taper.

At 52 weeks, the trial met its primary endpoint with 28% of Kevzara-treated patients achieving sustained remission compared with 10% for placebo. Sustained remission was defined as being in disease remission by week 12, absence of disease flare, C-reactive protein normalization from weeks 12 to 52, and adherence to the CS taper protocol from weeks 12 to 52.

The common adverse reactions occurring in patients treated with Kevzara were neutropenia, leukopenia, constipation, rash pruritic, myalgia, fatigue, and injection site pruritus. Serious adverse reaction of neutropenia occurred in two patients in the Kevzara group compared with none in the placebo group.