Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) seeking its approval for the treatment of Covid-19.
Presently, Veklury is being administered to hospitalised patients with severe Covid-19 under an emergency use authorisation (EUA) issued by the FDA.
According to Gilead Sciences, the latest drug filing for the investigational antiviral is the final tier of the rolling NDA submission it had initiated in early April 2020.
The NDA filing for Veklury is backed by results from two randomised, open-label, multi-centre phase 3 clinical studies carried out by Gilead Sciences along with a phase 3 randomised, placebo-controlled study of the same investigational drug held by the National Institute of Allergy and Infectious Diseases (NIAID).
The three phase studies could show that treatment with the investigational antiviral resulted in faster time to recovery in comparison with placebo, and that a five-day or 10-day treatment duration showed similar clinical improvement.
Gilead Sciences said that Veklury, across the studies, was well-tolerated in general for both the five-day and 10-day treatment arms, with no new safety signals detected.
Gilead Sciences chief medical officer Merdad Parsey said: “Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations.
“Today’s filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19.”
The antiviral candidate from Gilead Sciences has approvals from various regulatory authorities across the world, including in the European Union and Japan.
In India, two generic injectable formulations of remdesivir were approved in June for the treatment of patients with severe Covid-19 under the Central Drugs Standard Control Organisation’s restricted emergency use. One of them is COVIFOR from Hetero Drugs, while the other is CIPREMI from Cipla.
Remdesivir is a nucleotide analog, which is claimed to have a broad-spectrum antiviral activity in vitro and also in vivo in animal models against various emerging viral pathogens.