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EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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The European Medicines Agency (EMA) has started evaluating Roche’s anti-inflammatory medicine RoActemra (tocilizumab) to extend its potential use to hospitalised adult patients with severe COVID-19, who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation (breathing assisted by a machine).

RoActemra has already been approved by the FDA after demonstrating positive results for emergency use in hospitalised COVID-19 patients who needed oxygen in phase 3 clinical trials. The drug cut the risk of death among patients hospitalised with severe COVID-19, shortened the time to recovery and reduced the need for mechanical ventilation.

EMA’s human medicines committee (CHMP) will carry out an accelerated assessment, including results from four large randomised studies to decide whether the extension of indication should be authorised, with the outcome expected in mid-October.

Along with Sanofi's Kevzara, Roche’s Actemra was recommended in the World Health Organization’s updated patient care guidelines as a ‘life-saving’ drug for the treatment of COVID-19 patients.

This is EMA’s latest review of a potential coronavirus treatment, following announcements that it is evaluating an arthritis drug developed by Sweden’s Sobi to treat COVID-19 in adults with pneumonia, and Eli Lilly’s rheumatoid arthritis drug Olumiant to treat hospitalised COVID-19 patients receiving oxygen.

A study of Eli Lilly’s JAK inhibitor Olumiant in combination with Gilead’s antiviral med remdesivir met its primary endpoint in patients hospitalised with COVID-19, with remdesivir remaining the only drug currently authorised to treat COVID-19 in the European Union.

Article by
Bryony Andrews

17th August 2021

From: Regulatory

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