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

Drug Delivery Business

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

Acorda’s Parkinson’s device moves closer to E.U. approval

July 26, 2019 By Nancy Crotti

Acorda TherapeuticsAcorda's Inbrija device (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of  “off” episodes in people with Parkinson’s disease.

The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s therapy, carbidopa/levodopa, according to Acorda. The FDA approved Inbrija in December 2018.

The CHMP decision is based on a clinical trial for INBRIJA that included approximately 900 people with Parkinson’s on a levodopa/dopa-decarboxylase inhibitor regimen experiencing OFF periods. Results of the Phase 3 pivotal efficacy trial were published in The Lancet Neurology in February.

The Ardsley, N.Y.-based company said it expects a decision from the European Commission in the coming months.

“We are delighted that Inbrija has achieved this important milestone, and look forward to the E.C.’s final decision later this year,” said Acorda president & CEO Dr. Ron Cohen in a news release. “There are approximately 1.2 million people in the E.U. living with Parkinson’s. We estimate that 40% of these individuals experience ‘off’ periods, which are considered extremely disruptive. Acorda is currently evaluating partnering opportunities to commercialize Inbrija in Europe.”

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Uncategorized Tagged With: Acorda Therapeutics, European Union

IN CASE YOU MISSED IT

  • Another BD Alaris infusion pump recall is Class I
  • Amgen completes $1.9B acquisition of Five Prime Therapeutics
  • Oncopeptides seeks EU marketing authorization for multiple myeloma treatment
  • Horizon touts data from trials for thyroid eye disease infusion treatment
  • Genentech touts study results for spinal muscular atrophy drug in babies

Primary Sidebar

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 Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · 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.

Advertise | Privacy Policy | RSS