Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Orphan Drugs
  • R&D 100 Awards

FDA approves remdesivir as a COVID-19 treatment

By Sean Whooley | October 23, 2020

COVID-19

The FDA announced that it fully approved the use of remdesivir as a treatment for COVID-19 requiring hospitalization in all adult and some pediatric patients.

Remdesivir is only to be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. The drug, also referred to by the FDA as Veklury, is the first treatment for COVID-19 to receive FDA approval, according to an FDA news release. It can be used for adult patients and pediatric patiens who are over 12 years old and weigh more than 40 kg (88 lb).

The drug was recently in the news after it was announced that it was among the treatments given to President Donald Trump during his bout with COVID-19.

Gilead Sciences (NSDQ:GILD) already had received FDA emergency use authorization for remdesivir, and now has approval and also received a revised EUA that authorized use of the drug for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized patients less than 12 years old. There are ongoing clinical trials evaluating the safety and efficacy of remdesivir in this patient population.

Authorization for remdesivir came on the back of three separate randomized, controlled clinical trials, one of which found statistically significant clinical improvement, while the others saw favorable improvement that did not register as statistically significant.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Dr. Stephen M. Hahn said in the release. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.

“As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

Tell Us What You Think! Cancel reply

Related Articles Read More >

AstraZeneca-Oxford
Study finds AstraZeneca COVID-19 vaccine could be effective against Brazil variant
RCSB Protein Data Bank now has more than 1,000 SARS-CoV-2 proteins
Ivermectin not supported for mild COVID-19, study says
Novavax
Novavax stock dips 14% on the heels of Q4 announcement

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup

R&D Twitter

Tweets by @RandDWorld
Drug Discovery and Development
  • Enews Signup
  • Contact Us
  • R&D World
  • Pharmaceutical Processing
  • Drug Delivery Business News

Copyright © 2021 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Orphan Drugs
  • R&D 100 Awards