• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

AstraZeneca touts long-term safety, efficacy data for asthma biologic

September 18, 2018 By Sarah Faulkner

AstrazenecaAstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma.

Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan.

The Phase III extension Bora trial included people who had previously completed one of the two pivotal Sirocco or Calima Phase III trials.

In the 56-week Bora trial, investigators observed a safety and tolerability profile for Fasenra that was similar to the one observed in AstraZeneca’s pivotal trials. The participants’ improvements in efficacy measures were maintained over the year of additional treatment, researchers added.

The study participants who were treated with placebo in the pivotal trials and then transitioned to Fasenra in the Bora trial also experienced improvements in efficacy outcomes.

AstraZeneca noted that 74% of participants with a baseline blood eosinophil count of 300 cells per μL or greater who received Fasenra every eight weeks were exacerbation-free during the Bora trial and maintained improvements in lung function and asthma control.

The overall yearly asthma exacerbation rate for participants with baseline blood eosinophil counts of 300 cells per μL or greater was consistent throughout the Bora trial with the predecessor pivotal trials.

The most commonly-reported adverse events included upper respiratory tract infection, worsening asthma, headache, bronchitis and acute sinusitis, the company noted.

“The Bora data are important news for patients with severe eosinophilic asthma who need a treatment with sustained efficacy to help control their disease, and with a safety profile that supports long-term use,” Sean Bohen, EVP of global medicines development & CMO, said in prepared remarks.

“As a clinician, I am excited by the Bora trial results, which provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they are seeing with Fasenra can be maintained over a second year of treatment. In Fasenra, we have a biologic treatment that can improve outcomes for these patients long-term,” lead investigator Dr. William Busse added.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: AstraZeneca plc

IN CASE YOU MISSED IT

  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor
  • Medtronic to separate Diabetes business unit

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. 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 | RSS