1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Allergan Hopes To Add Bipolar Depression To Vraylar's Label

 
• By Joseph Haas

With Phase III success in bipolar depression, Allergan plans an sNDA in 2018 to add that indication to the atypical antipsychotic's label, which includes schizophrenia and bipolar mixed or manic episodes.

Profile of a human head with a colorful symbol of neurons in the brain

Positive Phase III data for atypical antipsychotic Vraylar (cariprazine) in depression associated with bipolar I disorder would appear to position the Allergan PLC drug for a supplemental new drug application (sNDA) filing in 2018, but the specialty pharma still doesn't know why the US FDA refused to file an sNDA for negative symptoms of schizophrenia in September.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By Joseph Haas

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By Kevin Grogan

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.

More from R&D

Moderna Punts On US Vaccine Policy Changes, Will Focus More On Cancer

 
• By Joseph Haas

On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.

Could There Be A Cure For Cardiometabolic Disease? Novo Nordisk Foundation Wants To Help Academics Find Out

 
• By Andrew McConaghie

The not-for-profit’s senior vice president Martin Ridderstråle explains how it is expanding grants for basic research to improve "human and planetary" health.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By Kevin Grogan

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.