Gilead’s antiviral treatment remdesivir has been approved by the US Food and Drug Administration (FDA) for the treatment of COVID-19 patients requiring hospitalisation.
Remdesivir – approved with the brand name Veklury – becomes the first and only treatment approved in the US for COVID-19.
The FDA has indicated remdesivir for use in adult and paediatric patients (12 years of age and older and weighing at least 40kg) for the treatment of COVID-19 requiring hospitalisation.
The approval is based on three randomised controlled trials including the recently published, final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) phase III ACTT-1 trial.
This trial showed that remdesivir treatment resulted in clinically meaningful improvements across a number of outcome assessments compared with placebo in hospitalised COVID-19 patients.
In the ACTT-1 trial, remdesivir significantly improved time to recovery compared to placebo. In the overall study population, the drug improved recovery time by five days and by seven days in patients who required oxygen support at baseline.
Remdesivir also reduced disease progression in patients requiring oxygen – a secondary endpoint – resulting in a significantly lower incidence of new mechanical ventilation or ECMO.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the US that is available for all appropriate patients in need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
“The speed and rigor with which Veklury has been developed and approved in the US reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery,” he added.