Remdesivir given fast-track approval to treat Coronavirus

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The U.K. approved using Gilead Sciences Inc.'s antiviral drug remdesivir for some patients hospitalized with Covid-19 after a study showed it can speed their recovery.

In the United Kingdom, the Recovery trial looking at using this drug in patients remains open, but another one, using it in frontline NHS staff to prevent rather than treat infections, has paused recruiting more volunteers. The majority of patients in either treatment arm were a grade 4 on the ordinal scale: receiving low-flow supplemental oxygen. In addition, more patients in the 10-day group required high-flow oxygen support. But the researchers noted the differences in mortality were not statistically significant.

About a week later, the Japanese government had also granted regulatory approval of remdesivir, which will be sold under the brand Veklury, as a treatment for covid-19 under an exceptional approval pathway. While the remidesivir group recovered in 11 days, people who were on placebo took 11 days to be cured.

There were serious adverse events in 114 (21.1%) of the patients in the remdesivir group and in 141 (27%) in the placebo group.

"There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients)".

A drug due to be trialled on selected NHS patients could be the "biggest step forward in the treatment of coronavirus since the crisis began", the health secretary has said.

Gilead Sciences Inc's antiviral drug is now undergoing large global clinical trials, including in the United Kingdom, and early data suggests it can cut recovery time by about four days.

Britain will provide the anti-viral drug remdesivir to certain COVID-19 patients that it is most likely to benefit as part of a collaboration with manufacturer Gilead Sciences, the health ministry said on Tuesday.

"Analysis of the relationship between remdesivir use and clinical status may also have implications for elucidation of the pathogenesis of SARS-CoV-2", they noted.

The study also suggested a survival benefit, with a 14-day mortality rate of 7 per cent for the group receiving remdesivir compared to almost 12 per cent for the placebo group.

"Further evaluation of this subgroup and of other high-risk groups, such as immunocompromised persons, is needed to determine the shortest effective duration of therapy", they concluded.

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