July 3, 2020 / 1:27 PM / a month ago

Gilead's COVID-19 antiviral remdesivir gets conditional EU clearance

BRUSSELS (Reuters) - The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region’s first authorised therapy to treat the virus.

The move comes just a week after the European Medicines Agency (EMA) gave its go-ahead for the drug, produced by Gilead Sciences, to be used in adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support.

It also comes just days after the company allocated nearly all of its supply of remdesivir to the United States over the next three months, stirring concerns about availability elsewhere.

“We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, in a statement.

The Commission said on Wednesday it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.

Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial.

It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.

Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.

The EU’s green light broadens the use of remdesivir around the world - the United States has cleared it for emergency use and it is also approved as a COVID-19 therapy in Japan, Taiwan, India, Singapore and the United Arab Emirates, Gilead said on Friday.

FILE PHOTO: Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo

A conditional marketing authorisation is one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfil an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic, the Commission said.

The approval is valid for one year in the bloc and can be extended or converted into an unconditional marketing authorisation if all necessary data are available on its efficacy and side effects.

The agency reviews data as they become available on a rolling basis, while development is still ongoing. The EMA’s rolling review began at the end of April.

Reporting by Philip Blenkinsop; Writing by Josephine Mason; Editing by Jane Merriman and Elaine Hardcastle

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