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EMA Recommends Remdesivir for Treatment of COVID-19 Under Compassionate-Use Rules

By Cory Renauer – Apr 3, 2020 at 1:51PM

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Accessing the experimental antiviral treatment outside of clinical trials just got easier in the European Union.

The European Union's health regulator on Friday took an unusual step and increased access to an experimental drug that might be effective against SARS-CoV-2, the coronavirus that causes COVID-19. Gilead Sciences' (GILD 3.99%) antiviral treatment remdesivir is now indicated for the treatment of adults unable to breathe due to COVID-19 as part of a compassionate-use program, said the European Medicines Agency.  

Not a full approval 

The EMA has not approved remdesivir for COVID-19 or any other indication, but the drug has been taken by dozens of Ebola patients and it didn't appear to have dangerous side effects. Remdesivir is supposed to prevent infected cells from producing copies of just about any virus, but there are only anecdotal reports so far of it being successful as a COVID-19 treatment. And, worth noting, it failed in clinical trials as an Ebola treatment, though there is speculation that may have been due to how late in the progression of the disease patients were given the drug.

The EMA would prefer for COVID-19 patients to receive remdesivir by participating in one of nine clinical trials that are ongoing at the moment or expected to begin soon. However, given the extremely poor prognosis for COVID-19 patients who have already lost the ability to breathe properly on their own, waiting around for a drug trial to begin isn't always an option.

Healthcare worker holding a coronavirus sample.

Image source: Getty Images.

What to look for

During the PALM study in 2018 and 2019, 681 Ebola virus patients were randomized into groups that received remdesivir or one of three other experimental antiviral drugs. After an interim analysis, patients in the remdesivir group were switched over to groups with lower mortality rates.

In April, Gilead Sciences expects to release interim results from a controlled clinical trial of remdesivir in COVID-19. And this summer,  Regeneron (REGN -0.50%) could begin clinical trials in which it treats COVID-19 patients with REGN-EB3, a cocktail of three monoclonal antibodies that outperformed remdesivir during the PALM study.

Cory Renauer owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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