Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50

European regulators approve Janssen’s twice-yearly schizophrenia treatment

By Brian Buntz | November 23, 2021

JanssenTwo months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate.

Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found that 92.5% of patients receiving the therapy were relapse-free at 12 months.

The Phase 3 study was a randomized, double-blind, non-inferiority trial including 702 adults with schizophrenia.

The drug won FDA approval in September, but its trade name in the U.S. is Invega Hafyera.

To be eligible for the drug, patients must be clinically stable on either once-monthly paliperidone palmitate (PP1M) or three-monthly paliperidone palmitate (PP3M).

Janssen formulated the drug to have exceptionally low water solubility, enabling it to offer continuous absorption over six months.

 

 


Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs
Tagged With: Byannli, paliperidone palmitate, schizophrenia
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Lab facility
Massachusetts is competing for ARPA-H biomedical research center
Blockchain
Startup vies to get blockchain adoption in pharma off the ground
Janssen
Janssen’s company group chairman dishes on growth strategy
Curebase
Curebase raises $40 million in Series B funding round 

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 Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

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 Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • The Pharma 50