Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA advisory committee votes in favor of COVID-19 pill molnupiravir

By Brian Buntz | November 30, 2021

Merck/RidgebackBioFDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks.

A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions.

FDA generally follows the advice of its advisory committees.

“This was clearly a very difficult decision,” said Dr. Michael D. Green, a member of the advisory committee and professor at the University of Pittsburgh School of Medicine. “I would use it in high-risk non-vaccinated individuals,” Green said, adding he would consider the drug for people with obesity and multiple other risk factors. “For pregnancy, I would only use it if there’s no alternative therapy available, and I don’t think I would use it in the first trimester.”

Committee members who voted ‘no’ voiced several concerns.

Dr. Timothy Burgess of the Uniformed Services University cited the unconvincing clinical data for his ‘no’ vote. “And I think there are concerns with respect to the uncertainty about the risk for genotoxicity,” he added. “I certainly recognize the need for additional therapeutic agents to be available, particularly with the emergence of developing clades and strains,” Burgess said. “But on the as the question is articulated on the basis of the available data, I voted ‘no.’”

Committee member Dr. Jennifer Le said she appreciated the pharmacologic safety data Merck provided, “yet the pre-marketing studies that we’ve seen here demonstrate highly relevant signals for safety concerns,” said Le, who is a professor of clinical pharmacy at UC San Diego.

Merck’s stock jumped $1.95% to $76.37 in after-hours trading.

Merck developed the drug in collaboration with Ridgeback Biotherapeutics.

If FDA decides to grant emergency use authorization to the drug, it would be the first oral COVID-19 antiviral available in the U.S.

The UK granted conditional approval to the drug in early November.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: Antimicrobial Drugs Advisory Committee, FDA, Merck, Molnupiravir, Ridgeback Biotherapeutics
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
Zoliflodacin wins FDA nod for treatment of gonorrhea
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

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.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 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 & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE