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www.fdanews.com/articles/203386-eu-names-four-antibodies-and-an-arthritis-drug-as-preferred-covid-19-therapies

EU Names Four Antibodies and an Arthritis Drug as Preferred COVID-19 Therapies

June 30, 2021

The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal antibodies and Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib).

The agency recommended antibodies from GlaxoSmithKline, Celltrion, Eli Lilly and Regeneron for use in early-stage patients at risk of progressing to severe COVID-19 and Olumiant for treatment of hospitalized COVID-19 patients on oxygen.

The EMA, which plans to expand its preferred list to include 10 treatments, released the list for use by regulatory authorities in EU member states. The only COVID-19 treatment currently approved in the EU is Gilead Sciences’ Veklury (remdesivir).

The listing of Olumiant followed a review by the EMA’s human medicines committee of possible therapies that could be repurposed as COVID treatments. Data from two clinical studies of hospitalized COVID-19 patients showed the treatment helped reduce hospitalizations, long COVID and mortality rates.

The FDA granted Olumiant Emergency Use Authorization in November for use in conjunction with remdesivir to treat COVID-19 patients needing supplemental oxygen (DID, Nov. 23, 2020). — Daphne Butas