Regeneron and Sanofi’s IL-6 Inhibitor Kevzara Becomes First FDA-Approved Biologic for Polymyalgia Rheumatica

On February 28, Regeneron and Sanofi jointly announced that the FDA has approved sarilumab (brand name: Kevzara) for the treatment of adult patients with polymyalgia rheumatica who have an inadequate response to or are intolerant of corticosteroid (CS) tapering. This is the first and only biologic therapy approved by the FDA for the treatment of this condition.

The FDA's approval this time is mainly based on the results of the Phase III clinical SAPHYR study of sarilumab in the treatment of polymyalgia rheumatica. A total of 118 subjects were enrolled in the trial and randomly divided into two groups, receiving either sarilumab 200mg + 14-week CS tapering (n=60) or placebo + 52-week CS tapering (n=58).

The results showed that at week 52, the trial met its primary endpoint, with more subjects in the sarilumab group achieving sustained remission compared to the placebo group (28% vs 10%, p=0.0193). Sustained remission was defined as disease remission at week 12, no disease flare, normal C-reactive protein (CRP) from weeks 12 to 52, and adherence to a CS tapering regimen from weeks 12 to 52.

In a sensitivity analysis excluding CRP from the definition of sustained remission, this significant difference was also observed, with proportions of patients achieving sustained remission in the sarilumab group and placebo group being 32% and 14%, respectively. Regarding secondary endpoints, the median cumulative CS doses in the two groups were 2044 mg vs 777 mg.

During the treatment period, common adverse events occurring in the sarilumab group included neutropenia (15%), leukopenia (7%), constipation (7%), etc., while no such adverse reactions were reported in the placebo group.

Sarilumab is a fully human monoclonal antibody that directly targets the interleukin-6 (IL-6) receptor, co-developed by Regeneron and Sanofi. It was first approved by the FDA in 2017 for the treatment of patients with rheumatoid arthritis. Reportedly, the product's sales reached 339 million euros in 2022.

Kevzara Annual Sales (Source: PharmaCube NextPharma Database)

Polymyalgia Rheumatica is an inflammatory rheumatic disease that can cause stiffness and pain in the shoulders, neck, and hips. It commonly occurs in middle-aged and elderly individuals over 50 years old and is more prevalent in women. The most common symptoms are pain and morning stiffness in the shoulder and pelvic girdle areas, along with general symptoms such as fatigue, fever, and weight loss.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reproduce it, please leave a message or send a notification to the WeChat Official Account backend, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Live Broadcast

CUBE LIVE