Veklury is now the first treatment to have been approved by the FDA for Covid-19.
It has been approved to be used in adult as well as paediatric patients, aged 12 years and older with a weight of at least 40kgs.
In May 2020, the FDA granted its emergency use authorisation (EUA) for Veklury for the treatment of Covid-19.
The regulator’s approval to the antiviral drug does not include the entire population that was authorised under the EUA.
The FDA has now revised the EUA to allow the drug’s use in suspected or laboratory confirmed Covid-19 in hospitalised children, weighing between 3.5kg and 40kg or hospitalised children aged less than 12 years and weighing at least 3.5 kg.
Veklury’s clinical trials to study the safety and efficacy in this particular paediatric patient population are in progress.
FDA Commissioner Stephen Hahn said: “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.
“As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Veklury has been approved based on the findings of three randomised controlled trials. These include the National Institute of Allergy and Infectious Diseases’ (NIAID) phase 3 ACTT-1 trial.
In the late-stage trial, the antiviral drug was shown to have delivered clinically meaningful improvements across various outcome assessments in hospitalised patients with Covid-19, in comparison to placebo treatment. The ACTT-1 trial featured 1,062 hospitalised patients having mild, moderate and severe Covid-19.
The median time to recovery from the viral infection was 10 days for the Veklury patient arm, compared to 15 days for the 521 patients who were given placebo.
Gilead Sciences chairman and CEO 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 U.S. that is available for all appropriate patients in need.”