Veklury becomes the first and only FDA approved treatment for Covid-19 in the US, which helps recovery of hospitalised Covid-19 patients
Gilead Sciences has received the US Food and Drug Administration (FDA) approval for its antiviral drug remdesivir, under brand name Veklury, to treat Covid-19 patients who require hospitalisation.
The US approval indicated remdesivir for the treatment of Covid-19 in hospitalised adults and pediatric patients, aged 12 years and above, administered in a hospital or healthcare setting.
Remdesivir is an investigational nucleotide analogue, which prevents the replication of SARS-CoV-2, the virus that causes Covid-19.
The drug is not advised for patients with previous clinically significant hypersensitivity reactions to Veklury or any of the related components.
In May 2020, FDA granted emergency use authorisation (EUA) for remdesivir. With the current approval, Veklury becomes the first and only approved treatment for Covid-19 in the US.
Gilead Sciences chairman and chief executive officer Daniel O’Day said: “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.
“The speed and rigor with which Veklury has been developed and approved in the U.S. 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.”
Phase 3 ACTT-1 and two SIMPLE Trials supported FDA approval for remdesivir
The FDA approval is based on three clinical trials, including two open-label Phase 3 studies, dubbed SIMPLE Trials, and a randomised, double-blind, placebo-controlled, Phase 3 clinical trial ACTT-1.
Results from the National Institute of Allergy and Infectious Diseases’ (NIAID) sponsored Phase 3 ACTT-1 trial showed that remdesivir improved multiple outcome assessments in hospitalised Covid-19 patients, compared to placebo.
Gilead has conducted two open-label Phase 3 trials, dubbed SIMPLE-Severe and SIMPLE-Moderate, in countries with a high frequency of Covid-19 infections, and included US trial sites serving diverse communities.
Nausea, increased AST and increased ALT include the most common adverse reactions in the SIMPLE-Severe trial, while nausea is the only common adverse reaction in SIMPLE-Moderate trial.
Albert Einstein College of Medicine professor Barry Zingman said: “The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources.
“The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalised patients and their families important hope, and offers healthcare providers a critical tool as they care for patients in need.”