GENE ONLINE|News &
Opinion
Blog

FDA Grants Emergency Use Authorization to Third COVID-19 Antibody Therapy

by Rajaneesh K. Gopinath
Share To

May 27th, 2021—After the emergency use authorization of antibody therapies from Regeneron, and Eli Lilly, the USFDA today has approved a third one today. GSK and Vir Biotechnology’s sotrovimab has been approved to treat patients aged 12 years and older with mild to moderate COVID-19, who are at high risk of progressing to severe disease.

In March, an independent monitoring committee found that sotrovimab was effective in early-stage COVID-19 patients at reducing the risk of hospitalization and death by 85%. This prompted the companies to seek regulatory clearance for the investigational monoclonal antibody therapy. After two months, it has now bagged the emergency nod in the US, just days after obtaining EMA approval.

 

COMET-ICE Trial

Sotrovimab’s FDA approval stems from the Phase 3 COMET-ICE trial involving 583 patients with mild to moderate COVID-19. The participants were either treated with sotrovimab (291 cases) or placebo (292 cases). Results showed that the number of hospitalizations and deaths in the sotrovimab arm was reduced by 85% (21 vs. 3) as compared to placebo. The antibody was also well tolerated by patients.

“Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk – allowing them to avoid hospitalization or worse,” said Dr. Adrienne E. Shapiro, an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial.

 

Effective Against Variants

For the EUA, GSK and Vir had also submitted sotrovimab’s in vitro data against circulating COVID-19 variants.

Sotrovimab targets a conserved epitope of SARS-CoV-2’s spike protein that is less likely to mutate over time. Therefore, the antibody maintained activity against all known circulating variants of concern, including the variants identified first in Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the UK (B.1.1.7), GSK said in a statement.

“The fast pace of COVID-19 vaccinations in the U.S. is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications. In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need,” said Dr. Hal Barron, CSO, and President R&D, GSK.

The updated safety and efficacy data from the ongoing COMET-ICE trial is expected in the first half of 2021. If favorable results are obtained, the companies plan to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.

VIR-7832, another antibody therapy jointly developed GSK and Vir, is currently evaluated in Phase 1b/2a AGILE trial, with sotrovimab to test its effectiveness in mild to moderate adult patients.

 

Approved Antibody Therapies for COVID-19

Prior to sotrovimab, the FDA approved Regeneron’s antibody cocktail REGEN-COV (Casirivimab and Imdevimab combo). In November 2020, Eli Lilly’s Bamlanivimab received EUA as monotherapy, but the FDA revoked it in mid-April 2021, citing the increase of COVID-19 variants resistant to the therapy.

The agency has also approved two antibody combo therapies, namely Eli Lilly’s Baricitinib (Olumiant) with remdesivir therapy and Bamlanivimab with Etesevimab.

Related Article: Vir, GSK’s Antibody Therapy Effective Against COVID-19 Variants, Reduces Hospitalization and Deaths by 85%

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
M&A
GSK Completed the Acquisition of Aiolos Bio, Enhancing the Respiratory Portfolio of Asthma
2024-02-16
GeneOnline’s Weekly News Highlights: Sept 17-Sept 22
2023-09-26
GeneOnline’s Weekly News Highlights: Sept 11-Sept 15
2023-09-19
LATEST
Innovative Cellular Mapping of BRCA-Related Breast Cancer Findings Reveals Novel Therapeutic Targets
2024-03-29
Previewing AACR 2024 With Select Pre-Meeting Highlights
2024-03-28
Roche Delivering on Malaria Screening Solutions for Blood Donation
2024-03-28
Innovating Cancer Treatment: The Role of ADC Technology at Nona Biosciences
2024-03-28
BIO CHINA 2024 Brings Biotech Experts and Industry Elites Together for Innovation
2024-03-27
Galderma’s Strong European IPO Debut
2024-03-26
Markets and Mergers: Boston Scientific and Axonics Shake Hands on Deal
2024-03-25
EVENT
2024-04-06
Biotech Innovation Funding Networking
Los Angeles, USA
Scroll to Top