EU drug watchdog to weigh in on extended use for remdesivir by summer

Europe’s drugs regulator said on Tuesday it was expecting to give an opinion before the summer on whether Gilead Sciences’ remdesivir can be used to treat COVID-19 patients who do not need oxygen support.

The indication for extended use, if approved, would allow the antiviral treatment to be given to more patients as coronavirus infections surge and healthcare systems are pressured by emerging, highly transmissible variants of the virus.

U.S.-based developer Gilead has submitted data to the European Medicines Agency (EMA), the watchdog said, adding that its human medicines committee had started evaluating the latest submissions.

The European Union had conditionally approved remdesivir, the first COVID-19 therapy on the continent, in July last year for treating COVID-19 in adults and adolescents over 12 years with pneumonia requiring oxygen support.

Any potential endorsements by the EMA, which have to be formally approved by the European Commission, would also help Gilead to broaden sales of a hot-selling treatment that helped boost its fourth-quarter revenue.

The U.S. drugmaker earlier this month forecast 2021 sales of up to $3 billion for remdesivir, which is sold under the brand name Veklury.