Skip to main content

Market Overview

Incyte's Ruxolitinib Fails To Beat Placebo In Improving Mortality In Critically-Ill COVID-19 Patients

Share:

Incyte Corporation NASDAQ: INCY) announced results from the Phase 3 DEVENT study evaluating two doses of ruxolitinib (5mg and 15mg) plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

  • While improvement in mortality for each dose compared to placebo was trending positive, the study failed to meet its primary endpoint.
  • Mortality due to any cause through day 29 between the two treatment arms versus placebo was (55.2% vs. 74.3%) in the 5mg arm and 51.8% vs. 69.6% in the 15mg arm.
  • In the U.S. study population (N=191), clinically and statistically significant improvement in mortality was observed in each of the 5mg (46.7% vs. 69.1%) and 15mg treatment arms (47.1% vs. 66.7%) versus placebo, respectively.
  • Additionally, a post-hoc analysis of the overall study population pooling both the 5mg and 15mg ruxolitinib arms together versus placebo showed a statistically significant improvement in mortality (53.6% vs. 70.7%)
  • 55% of study patients received remdesivir, and 90% of study patients received corticosteroids before or during the study.
  • The most common adverse events on the ruxolitinib arms, compared to placebo, were anemia (20.7% vs. 22.2%), increased alanine aminotransferase (14.6% vs. 13.3%), increased aspartate transaminase (14.0% vs. 8.9%), and hypertension (11.6% vs. 11.1%), respectively.
  • The company plans to make ruxolitinib available to eligible patients in the U.S. via an Expanded Access Program pending agreement with the FDA.
  • Price Action: INCY shares closed 2.4% lower at $78.25 on Thursday.
 

Related Articles (INCY)

View Comments and Join the Discussion!

Posted-In: COVID-19 CoronavirusBiotech News Health Care FDA General

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com