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Update from Sanofi Regarding Kevzara

Sanofi is currently experiencing an increase in worldwide demand for sarilumab (Kevzara) due to an increase in the global demand for IL-6 receptor blockers and the ttemporary tocilizumab shortage.

Due to this exceptional demand, supply for all four formats of sarilumab (150mg or 200mg pre-filled syringe or auto-injector) is expected to be constrained until early 2022 based on current forecasts.

Various country and global health authorities have recommended IL-6 receptor blockers for the treatment of patients with severe or critical COVID-19. Sarilumab is not approved or authorized for emergency use for the treatment of COVID-19 anywhere in the world, and Sanofi will continue to prioritize access for indicated patients with rheumatoid arthritis.

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Sanofi is working diligently to manage supply to minimize the impact of this increase in demand, and we are committed to proactive and timely communication as the situation evolves.

About Kevzara (sarilumab) Injection
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 and has been associated with disease activity, joint destruction and other systemic problems.

European Medicines Agency. (2021, September 3, 2021). RoActemra (tocilizumab)

Temporary s upply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL
c oncentrate for solution for infusion (IV) & recommendations to manage potential risk of disease f lare in patient.

The use of sarilumab to treat patients with COVID-19 is investigational and has not been approved or authorized for emergency use by any regulatory authority. Randomized controlled studies conducted by Sanofi and our collaboration partner, Regeneron, did not show a benefit and development of sarilumab for COVID-19 was discontinued.

Source: Sanofi
Date: Oct 12, 2021

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