chuka_lis (chuka_lis) wrote,
chuka_lis
chuka_lis

Ремдесивир -одобрен

Ремдесивир одобрен Food and Drug Administration в США для применения  при лечении ковид.
Хорошая новость.
Открытое письмо на сайте компании.
Nine months later, results from the randomized, controlled trials of Veklury involving thousands of patients have been published in peer-reviewed journals, conclusively demonstrating the clinical benefits of treatment with Veklury. In clinical research, the gold standard for demonstrating the efficacy and safety of a drug is the randomized, double-blind, placebo-controlled trial. This type of study reduces the potential for bias and provides the highest quality scientific evidence. The National Institute of Allergy and Infectious Diseases’ ACTT-1 trial of Veklury in hospitalized adult patients with moderate to severe COVID-19 is one such trial. We know from the ACTT-1 trial that Veklury leads to a five-day faster recovery in hospitalized patients overall, and a seven-day faster recovery in people who required oxygen support at baseline.[i] We also know that Veklury reduces the likelihood of patients requiring new or more intensive oxygen support.[i] And, we have seen evidence that Veklury may reduce the likelihood of death, with a numerical trend toward reduced mortality in the overall ACTT-1 population[i] and, in a post-hoc analysis, a reduction in mortality in patients on low-flow oxygen at baseline.[ii] There was no difference in mortality in other subgroups.[ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge.

Based on the ACTT-1 trial results and the data from two Gilead-sponsored global, randomized, open-label Phase 3 trials, the FDA approved Veklury for adults and adolescents (at least 12 years of age and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury is contraindicated in patients who are hypersensitive to remdesivir or any of its components; please see below for additional important safety information.

 

Tags: коронавирус, лекарство
Subscribe
  • Post a new comment

    Error

    Anonymous comments are disabled in this journal

    default userpic

    Your reply will be screened

    Your IP address will be recorded 

  • 19 comments