The New Drug Utility (NDA) for remdesivir (Veklury®; Gilead Sciences) has been submitted to the Meals and Drug Administration (FDA) for the remedy of sufferers with coronavirus illness 2019 (COVID-19).
Remdesivir is an investigational nucleotide analogue with broad-spectrum antiviral exercise. It's at the moment accessible within the US below an Emergency Use Authorization (EUA) for sufferers with suspected or laboratory-confirmed extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) an infection and extreme COVID-19. The rolling NDA submission was initiated on April 8, 2020.
The appliance is supported by information from 2 randomized, open-label, multicenter part three medical research (NCT04292730 and NCT04292899) carried out by Gilead and a randomized, placebo-controlled, part three research (NCT04280705) carried out by the Nationwide Institute of Allergy and Infectious Ailments (NIAID). The research evaluated the efficacy and security of remdesivir in hospitalized sufferers with COVID-19. Sufferers have been administered 200mg of remdesivir intravenously on the primary day, adopted by 100mg each day thereafter for five or 10 days.
Outcomes from these research confirmed a sooner time to restoration in sufferers handled with remdesivir in contrast with placebo. Furthermore, the research demonstrated related medical enchancment with the 5-day and 10-day remedy regimens. As for security, remdesivir was discovered to be nicely tolerated with no new security indicators recognized.
“For the reason that starting of the pandemic, Gilead has labored with urgency to ascertain the efficacy and security profile of Veklury, and we now have a strong information set supporting the analysis of use of the drug throughout a spread of hospitalized COVID-19 affected person populations,” mentioned Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “At present’s submitting is a vital milestone as we proceed to accomplice with the US authorities and healthcare authorities across the globe to handle the remedy wants of sufferers with COVID-19.”
For extra info go to gilead.com.
Gilead submits New Drug Utility to US Meals and Drug Administration for Veklury® (remdesivir) for the remedy of COVID-19. https://www.businesswire.com/news/home/20200810005486/en/Gilead-Submits-New-Drug-Application-U.S.-Food. Accessed August 10, 2020.
This text initially appeared on MPR