Pharmaceutical Processing World

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

European Commission Approves Shire’s VPRIV(R) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease

By Pharmaceutical Processing | August 27, 2010

Shire plc has announced that the European Commission has granted marketing authorization for VPRIV(R) (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.

VPRIV has been authorized as an orphan medicine through the Centralized Procedure, making it available in 30 countries across Europe.

This approval was based on data from Shire’s velaglucerase alfa clinical development program which represents the largest and most comprehensive clinical data set supporting registration for an ERT for type 1 Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints.

“Gaucher disease is a rare and often debilitating condition,” said Professor Tim Cox from the Department of Medicine, University of Cambridge, and founder of the largest U.K. Gaucher clinic at Addenbrooke’s Hospital. “The European approval of VPRIV is important in that we now have an alternative, licensed therapeutic enzyme. For type 1 patients the availability of VPRIV provides further opportunities to individualise treatment options for this complex disorder.” Across Europe, hundreds of type 1 Gaucher patients have been receiving velaglucerase alfa through early access programmes, developed in partnership with national authorities, Gaucher expert physicians and patient associations. Globally there are over 850 patients on velaglucerase alfa and demand continues to be strong. As a result, Shire has implemented a program to carefully monitor demand and manage requests from physicians and patients in order to ensure long-term, uninterrupted treatment with VPRIV.

“The Marketing Authorisation for VPRIV in the EU is an important milestone for Shire,” said Sylvie Gregoire, President, Shire Human Genetic Therapies. “Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the US months ahead of schedule.”   

 

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