Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

FDA updates ad comm meeting date for sabizabulin in hospitalized COVID-19 patients  

By Brian Buntz | September 19, 2022

VeruThe oncology biopharma Veru (Nasdaq: VERU) has announced that the FDA has moved the date for its Pulmonary-Allergy Drugs Advisory Committee to discuss the potential emergency use authorization (EUA) of sabizabulin for hospitalized COVID-19 patients.

The meeting is now slated for November 9, 2022.

It was originally scheduled for October 6, 2022.

VERU shares skidded almost 15% to $12.15 in early afternoon trading.

In particular, the Miami-based company aims to obtain EUA or COVID-19 patients with an elevated risk of developing acute respiratory distress syndrome (ARDS).

In April, the company shared positive efficacy and safety data from an interim analysis of a Phase 3 study evaluating oral sabizabulin 9 mg against a placebo.

The company halted the study after an independent data monitoring committee unanimously recommended doing so.

The primary endpoint for the drug was reducing the proportion of deaths by Day 60.

The committee concluded that sabizabulin effectively reduced deaths based on a planned interim analysis involving 150 randomized patients. In the placebo-controlled study, sabizabulin led to a 55.2% relative death reduction.

The company also concluded there were no safety concerns.

The FDA advisory committee plans to discuss the treatment effect size, including the high placebo mortality rate. It will also consider the limited scope of the safety database and discuss the proposed COVID-19–related population for sabizabulin.

The study involved 204 hospitalized COVID-19 patients with moderate to severe COVID-19 infections facing a high risk for ARDS and death.

Sabizabulin is a tubulin inhibitor. It has anti-inflammatory and antiviral properties.

Veru announced that data from the study would be published in The New England Journal of Medicine Evidence.

In the United Kingdom and Australia, sabizabulin’s marketing authorization application has received expedited review.

The European Medicines Agency’s Emergency Task Force announced on July 27 that it would be reviewing an application for emergency use in the European Union.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

Tell Us What You Think! Cancel reply

Related Articles Read More >

institut pasteur dakar IPD African Union vaccine investment
African Union vaccine initiative receives $45M
Sen-Jam Pharma, KVK-Tech partnering for manufacturing and formulation for anti-inflammatory injectables
This image shows the Moderna logo.
Moderna resizes its manufacturing footprint for a post-pandemic era
This is the logo of Pfizer.
Pfizer to close Durham and Morrisville, North Carolina facilities amid major restructuring effort
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

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 Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE