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Gilead’s Remdesivir Lowers Risk of Mortality in COVID-19 Patients
In other COVID news, GSK and Vir confirm the efficacy of their coronavirus antibody in COVID-19 patients, and AstraZeneca will supply 300M doses of its vaccine to the EU by the end of September.
Gilead recently announced that its COVID-19 treatment, remdesivir, lowered the risk for mortality compared with matched controls in patients hospitalized with the virus.
The three real-world data analyses analyzed included 98,654 patients. Two of the studies observed treatment trends and outcomes in the US, while the third analysis compared clinical outcomes in patients receiving a 10-day treatment course of remdesivir in the global SIMPLE-Severe study with patients receiving standard of care in a real-world cohort study.
For example, in the double-blind, placebo-controlled ACTT-1 trial, there was a trend of reduced mortality at Day 29, 11 percent versus 15 percent in patients treated with remdesivir versus placebo.
Additionally, patients requiring low-flow oxygen at baseline who received remdesivir achieved a statistically significant 70 percent reduction in mortality at Day 29.
All the analyses utilized pre-specified endpoints and best practice methodologies. And they were conducted in collaboration with independent experts in real-world comparative effectiveness research.
“Large real-world datasets with greater sample sizes and robust methodologies can be helpful to assess treatment effects in both the overall patient population and in clinically relevant subsets of patients,” Robert L. Gottlieb, MD, PhD, a cardiologist at Baylor University Medical Center and Baylor Scott & White Research Institute, said in the announcement.
“These real-world analyses provide clinicians with additional data on the efficacy of remdesivir (Veklury) in patients hospitalized with COVID-19, including its effect on mortality and likelihood of discharge from the hospital,” Gottlieb continued.
FDA approved remdesivir as the first COVID-19 treatment in October 2020 for use in patients 12 years of age or older infected with the coronavirus.
GSK, Vir Biotechnology Confirm Efficacy of COVID-19 Antibody in Phase 3 Trial
GSK and Vir Biotechnology recently announced that their COVID-19 antibody, sotrovimab, significantly reduced the risk of hospitalization or death among high-risk adult outpatients with mild-to-moderate coronavirus in the Phase 3 COMET-ICE trial.
The primary efficacy of all 1,057 enrolled in the trial demonstrated a 79 percent reduction in hospitalization for over 24 hours or death by Day 29 compared to placebo, a GSK spokesperson stated.
Just six patients in the sotrovimab group and 30 patients in the placebo group were hospitalized for less than 24 hours for acute management of any illness or death.
The most common adverse events in the trial were mild. The companies noted that they will submit full COMET-ICE data to a peer-reviewed journal for publication.
“Effective medicines to treat those who become infected with SARS-CoV-2 remain a critical part of the solution to this pandemic. We are working diligently to increase access to sotrovimab in the U.S. and across the globe, including evaluating the potential to simplify administration with an intramuscular formulation,” Christopher Corsico, senior vice president of development at GSK, said in the announcement.
In addition to the positive trial results, GSK highlighted that NIH recently updated its guidelines regarding the emergency use authorizations of COVID-19 antibodies to recommend the use of sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression.
AstraZeneca to Supply 300M Doses of COVID-19 Vaccine to the EU
AstraZeneca recently announced that it has welcomed the Court of First Instance in Brussels ruling to supply its COVID-19 vaccine, Vaxzevria, to Europe.
The European Commission requested 120 million doses of the vaccine by the end of June 2021, totaling 300 million doses by the end of September 2021.
So far, AstraZeneca has supplied over 70 million doses of Vaxzevria to the European Union to date and is expected to exceed 80.2 million doses delivered by the end of this month. Notably, the Court found that the European Commission has no exclusivity or right of priority over all the other contracting parties.
But AstraZeneca is committed to broad and equitable distribution of the vaccine as highlighted in the Advanced Purchase Agreement of August 2020.
“We are pleased with the Court’s order. AstraZeneca has fully complied with its agreement with the European Commission and we will continue to focus on the urgent task of supplying an effective vaccine, which we are delivering at no profit to help protect people in Europe and around the world from the deadliest pandemic in a generation,” Jeffrey Pott, general counsel, said in the announcement.
