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Allergan Confident Data Support Bipolar Depression Addition To Vraylar's Label

 
• By Sten Stovall

After recording its third positive pivotal trial in bipolar depression, Allergan will now file an sNDA for Vraylar in the second half of 2018.

Depression
Allergan Has Good Vraylar Topline Data From 3 Pivotal Bipolar I Depression Studies • Source: Shutterstock

Allergan PLC and Gedeon Richter PLC believe they now have adequate evidence for their atypical antipsychotic drug Vraylar (cariprazine) in the treatment of bipolar I depression to file an sNDA with the FDA in the second half of this year. Vraylar is currently approved for the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder.

The duo said it could now press ahead with the new cariprazine filing armed with positive top-line evidence from three pivotal placebo-controlled studies in bipolar I depression, RGH-MD-53, RGH-MD-54 and RGH-MD-56 after data from the former study met primary and key secondary efficacy endpoints

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.