Remdesivir FDA approval : Gilead Sciences, a California-based biopharma company, has bagged approval from the US Food and Drug Administration (FDA) for its antiviral drug Veklury (remdesivir) for Covid-19 treatment in patients requiring hospitalization.
This makes remdesivir the first approved treatment for coronavirus in the US.
Remdesivir FDA approved indication : Veklury has been approved by the FDA for the treatment of adults and pediatric patients, aged 12 years and who weigh a minimum of 40 kilograms.
The antiviral drug from Gilead Sciences has already been used for Covid-19 treatment under the emergency use authorization (EUA) issued by the FDA in May 2020 amid huge number of corona cases in the US.
It has to be noted that Remdesivir FDA approval does not cover the entire population that was authorized to be treated by the drug under the emergency use authorization.
To address this, the FDA has revised the emergency use authorization to cover those who are suspected to have Covid-19 or are confirmed to have as per lab tests and are aged under 12 years or weigh between 3.5 kilograms and 40 kilograms. The FDA said that clinical trials are going on to understand the safety and efficacy of Veklury (remdesivir) in this type of pediatric population.
Stephen M. Hahn – FDA Commissioner, commenting on Gilead Sciences remdesivir FDA approval, said: “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency.
“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 (remdesivir) has been approved by the FDA based on the data of three randomized, controlled trials in Covid-19 patients hospitalized with mild-to-severe symptoms.
One of the three remdesivir clinical trials is the phase 3 ACTT-1 trial sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
In the ACTT-1 Covid-19 clinical trial, remdesivir could provide clinically meaningful improvements in multiple outcome assessments in the participating patients, in comparison to placebo.
The average Covid recovery time for patients treated with Veklury (remdesivir) was 10 days in the ACTT-1 clinical trial, compared to 15 days for those in the placebo group.
Commenting on Gilead Sciences remdesivir FDA approval, Daniel O’Day – Chairman and CEO of Gilead Sciences, 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.
“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. 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.”
In July 2020, Gilead Sciences was given conditional marketing authorization for Veklury (remdesivir) from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind Covid-19. Read more about – Veklury EU approval for Covid-19 treatment here.