Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

CSL Behring Receives Canadian Notice of Compliance for Berinert

By Pharmaceutical Processing | June 2, 2010

CSL Behring Canada announced today that it has received Notice of Compliance for Berinert (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity. HAE is a rare and serious genetic disorder.

Berinert is the first and only therapy approved for the treatment of hereditary angioedema in Canada. The approval is based on the results of the phase II/III prospective, double-blind, placebo-controlled, randomized, International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy of pasteurized Human C1esterase inhibitor (C1-INH) concentrate.

I.M.P.A.C.T. was the world’s largest HAE trial ever.

“The approval of Berinert in Canada marks an important milestone in CSL Behring Canada’s ongoing commitment to addressing the unmet needs of hereditary angioedema patients,” said Dr. Heinz Neuhaus, General Manager of CSL Behring Canada. “CSL Behring is a leader in developing safe, effective and innovative therapies for use in treating patients who have rare and serious disorders. We are pleased to once again expand our rapidly growing portfolio of such products.” The approval of Berinert marks a historic turning point for patients with Hereditary Angioedema and their families, according to Tina Morgan, President, Canadian Immunodeficiencies Patient Organization. “Now that this treatment is available, patients suffering from hereditary angioedema attacks related to C1 Esterase Inhibitor Deficiency have access to a licensed replacement therapy that replaces what their own body fails to produce adequately. This treatment also has a favorable long term side effects profile, which is particularly important for patients suffering from HAE,” said Morgan.

    

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Pfizer-BioNTech vaccine vial
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
FDA logo
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
FDA logo
FDA sends warning letters to CBD and delta-8 THC product vendors

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.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 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
  • R&D 100 Awards