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AbbVie’s Blockbuster Vraylar Adds Significant Indication, Adjunctive MDD

 
• By Joseph Haas

Already selling at a run rate above $2bn annually, AbbVie predicts the atypical antipsychotic could reach the $4bn mark with a new US indication for adjunctive treatment of major depressive disorder.

FDA approved
Adjunctive MDD is Vraylar's fourth US label indication • Source: Shutterstock

AbbVie Inc. has obtained a supplemental US approval for atypical antipsychotic Vraylar (cariprazine) that the company and at least one analyst believe could add a billion-dollar opportunity to the drug’s existing label. The Chicago pharma revealed late on 16 December that the US Food and Drug Administration approved Vraylar as an adjunctive treatment for major depressive disorder in adults.

A D3-preferring dopamine D3/D2 receptor partial agonist, Vraylar is approved in the US for bipolar disorder and schizophrenia

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In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 
• By Andrew McConaghie

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

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.

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Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

 
• By Vibha Ravi

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.