Not long after the disappointing results from the World Health Organization’s Solidarity trial, remdesivir gets thumbs up from the FDA.
The antiviral drug Velkury (remdesivir), produced by Gilead Sciences becomes the first to receive approval for hospitalised patients diagnosed with Covid-19 and aged 12 years and above. Intended to be administered in a hospital or acute-care facility setting, and to patients weighing 40 kg and above, the drug leads the pack of candidates benefiting from the US federal agency’s Coronavirus Treatment Acceleration Programme which highlights the agency’s commitment to helping expedite the development and distribution of Covid-19 treatments.
The approval is supported by data pooled from three randomized, controlled trials which included hospitalized participants with mild-to-severe Covid-19 symptoms. Having previously received the FDA’s Fast Track and Priority Review designations, the antiviral drug had also been on the receiving end of negative publicity following the World Health Organization’s mid-October announcement that the drug seemed to offer little to no effect in reducing the severity or duration of symptoms.