The US regulatory agency has previously granted an Emergency Use Authorisation (EUA) for remdesivir, allowing the treatment of hospitalised severe Covid-19 patients
Ultrastructural morphology exhibited by coronaviruses. (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM/commons.wikimedia.)
Gilead Sciences has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its antiviral drug remdesivir, branded as Veklury, to treat patients with Covid-19.
The US regulatory agency has previously granted an Emergency Use Authorisation (EUA) for remdesivir, facilitating the treatment of hospitalised severe Covid-19 patients.
The regulatory submission indicates the final stage of the rolling NDA submission, which was stared on 8 April 2020, said the pharmaceutical company.
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 the use of the drug across a range of hospitalised Covid-19 patient populations.
“Today’s filing is an important milestone as we continue to partner with the US government and healthcare authorities around the globe to address the treatment needs of patients with Covid-19.”
Remdesivir showed antiviral activity against various emerging viral pathogens
Remdesivir is an investigational nucleotide analogue that shows wide-ranging antiviral activity in animal models, against various emerging viral pathogens.
The safety and efficacy of the drug are being evaluated under various international Phase 3 clinical trials, for the treatment of SARS-CoV-2 infection in different patient populations, formulations, and in combination with other therapies.
The submission of NDA for remdesivir is based data from two Phase 3 clinical trials, individually conducted by Gilead the National Institute of Allergy and Infectious Diseases (NIAID).
In the clinical studies, patients treated using remdesivir needed less time to recover than patients treated with placebo and treatment for five days or 10 days duration has also shown similar clinical improvement.
Also, the drug was generally well-tolerated in the clinical trials, in both the treatment groups, with no new safety signals identified.
Gilead said that remdesivir has been approved in the EU and Japan, but not approved in the US. The drug is being used only for investigational purposes as its safety and efficacy were not established yet.