Gilead’s Veklury (remdesivir) has become the first COVID-19 drug approved in the US following a nod from the FDA. As an antiviral drug, remdesivir works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Originally intended as a treatment for Ebola virus, remdesivir made… Read More »Gilead’s remdesivir finally gets US approval
Shots: The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC.… Read More »Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19
While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
Date: October 19, 2020 Issue #: 1609 Summary: Remdesivir (Veklury – Gilead), an investigational antiviral drug administered by IV infusion, is now available through an FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in all hospitalized patients. An earlier EUA limited use of the… Read More »Timing of Remdesivir for COVID-19
In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.
Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was… Read More »Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.