U.K.’s severe COVID-19 patients gain early access to remdesivir, at no cost to NHS
The U.K. will make remdesivir available to patients with severe COVID-19 before Gilead’s antiviral is officially approved.
Gilead Sciences Inc. (NASDAQ:GILD) will provide remdesivir to the U.K.’s NHS free of charge throughout the Early Access to Medicines Scheme (EAMS) period, which lasts for a year.
The Medicines and Healthcare products Regulatory Agency (MHRA) published on Tuesday a positive scientific opinion for remdesivir’s use via EAMS. Taking into account the threat posed by the COVID-19 pandemic, “the risks associated with remdesivir can be managed and do not outweigh the benefits,” MHRA said.
The opinion covers the use of remdesivir in adults and adolescents hospitalized with severe COVID-19, including those requiring supplemental oxygen or ventilation. It also cites data from NIH’s Phase III ACTT study that showed remdesivir reduced the time of recovery from 15 days to 11 days in patients with severe COVID-19 “and possibly also reduced the proportion of people dying.”
While data from the trial, reported Friday in The New England Journal of Medicine, support the antiviral’s use, they also show the drug isn’t likely to benefit the sickest patients (see “Ventilated COVID-19 Patients Unlikely to Benefit”).
A risk management plan for remdesivir has been developed, and information will be collected from patients who enter the scheme to monitor any potential side effects.
Japan approved remdesivir as Veklury to treat COVID-19 on May 7. FDA granted the antiviral Emergency Use Authorization on May 1 to treat certain COVID-19 patients with severe disease.