(Reuters) – Europe’s drugs regulator on Friday recommended changing some terms of the conditional approval given to antiviral drug remdesivir as a COVID-19 treatment, to make clear the conditions under which it can be used.
Doubts over remdesivir’s effectiveness were raised after the World Health Organization (WHO) last month said the drug should not be used for COVID-19 patients, regardless of how ill they are, just months after Europe and the United States approved the treatment.
The new terms of the conditional marketing authorisation in Europe add that a patient could need “low- or high-flow oxygen or other non-invasive ventilation at start of treatment,” according to the European Medicines Agency. (https://bit.ly/2W4BQb9)
The drug, made by U.S. drugmaker Gilead Sciences Inc, is already indicated for use in Europe in patients aged 12 years and older with body weight at least 40 kg, who are also suffering from pneumonia and require oxygen support.
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The European Union in October agreed to pay more than 1 billion euros ($1.2 billion) to Gilead for a six-month supply.
Research by British scientists showed remdesivir’s benefits, but a WHO-lead trial found there was no evidence the drug improves survival or reduces the need for ventilation, a claim Gilead has questioned.
The top U.S. infectious disease medical association had backed remdesivir for COVID-19 treatment days after the WHO warning.
A EU conditional marketing authorisation allows a treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side-effects are available.
($1 = 0.8247 euros)
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Sriraj Kalluvila and Shounak Dasgupta)