Cart is empty
View Cart
Subtotal: $0.00
JOIN NOW!
  • ABOUT US
    • Board of Directors
    • Benefits
    • Volunteering
      • Volunteer Opportunities
      • EDEI Committee
      • Education
      • Emerging Leaders
      • Local GAMP CoP
      • Membership
      • Product Show
      • Social
      • Student Development
      • Women in Pharma®
    • Students
      • Student Chapters
      • Career Workshop
      • Scholarships
    • Chapter Awards
      • NEW Chapter Awards 2024
    • Sponsors
    • Contact Us
  • EVENTS
    • Chapter Calendar
    • Educational Programs
    • Social Events
    • Student Activities
    • Product Show
    • Past Events
  • RESOURCES
    • Scholarship Foundation
      • Scholarship Application
    • Podcast
    • Documents
    • Chapter YouTube Channel
    • ISPE Publications
    • ISPE Guidance Documents
    • Member Directory
    • ISPE Training
    • ISPE Communities of Practice
  • BLOG
    • Boston Chapter Blog
      • Contribute
    • ISPE Blog
  • CAREERS
    • Job Board
    • Post a Job
  • Gallery
  • SCHOLARSHIP FOUNDATION
    • About the Foundation
    • Apply for a Scholarship
    • Donate
  • ABOUT US
    • Board of Directors
    • Benefits
    • Volunteering
      • Volunteer Opportunities
      • EDEI Committee
      • Education
      • Emerging Leaders
      • Local GAMP CoP
      • Membership
      • Product Show
      • Social
      • Student Development
      • Women in Pharma®
    • Students
      • Student Chapters
      • Career Workshop
      • Scholarships
    • Chapter Awards
      • NEW Chapter Awards 2024
    • Sponsors
    • Contact Us
  • EVENTS
    • Chapter Calendar
    • Educational Programs
    • Social Events
    • Student Activities
    • Product Show
    • Past Events
  • RESOURCES
    • Scholarship Foundation
      • Scholarship Application
    • Podcast
    • Documents
    • Chapter YouTube Channel
    • ISPE Publications
    • ISPE Guidance Documents
    • Member Directory
    • ISPE Training
    • ISPE Communities of Practice
  • BLOG
    • Boston Chapter Blog
      • Contribute
    • ISPE Blog
  • CAREERS
    • Job Board
    • Post a Job
  • Gallery
  • SCHOLARSHIP FOUNDATION
    • About the Foundation
    • Apply for a Scholarship
    • Donate
Alnylam Wins EU Approval of Onpattro

Alnylam Wins EU Approval of Onpattro

  • Posted by ISPE Boston
  • On September 12, 2018

Alnylam Pharmaceuticals has announced the European Commission (EC) has granted marketing authorization for Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The approval was granted less than three weeks after Alnylam won FDA approval for Onpattro. The drug is based on Nobel Prize-winning science and is the first-ever RNA interference (RNAi) therapeutic to be approved in either the US or Europe.

“Today’s approval is the result of many years of dedicated effort and marks the next step towards bringing a potentially life-changing treatment to patients with hATTR amyloidosis and their families. Patisiran has been shown to improve polyneuropathy, quality of life and activities of daily living,” said Theresa Heggie, Head of Europe, Alnylam Pharmaceuticals. “This is the start of a new chapter in the treatment of this rare, rapidly progressive, fatal disease…”

Many serious, chronic and life-threatening diseases, such as hATTR amyloidosis, are caused by a fault or mutation that interferes with the way the body manufactures proteins. RNAi is a completely new approach to the treatment of these diseases; targeting the faulty protein that is causing the disease rather than treating the symptoms. RNAi therapeutics are an entirely new class of medicines.

The European Medicines Agency reviewed patisiran under the accelerated assessment procedure that is granted to medicines judged to be of major interest for public health and therapeutic innovation. (Source: Alnylam Pharmaceuticals Website, 30 August, 2018)

Share this
 

1 Comment

Kevin Chronley
  • Sep 14 2018
  • Reply
Another step in bio-innovation delivering health care solutions. Well done Alnylam team!

Leave Reply Cancel reply

Leave a Comment

Your email address will not be published. Required fields are marked *

Post Categories
  • Podcasts (1)
  • Industry Buzz (556)
  • Chapter News (535)
  • Knowledge & Training (79)
  • Students & YP (78)
  • Career Tools (13)
Get Updates via Email




“Sounds Like Magic to Me” - Optimizing Facilities through Innovations & Technologies at the Product Show

Previous thumb

Broad Institute's CRISPR Patent Affirmed

Next thumb
Scroll
Follow Us
Search this Site
@2024 ISPE Boston Chapter. All rights reserved.