AbbVie’s Blockbuster Vraylar Adds Significant Indication, Adjunctive MDD

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. The bipolar...

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

More from New Products

Pipeline Watch: Ten Approvals And Seventeen 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.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten 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.

More from Scrip

Novo And Lilly Lay Out Patient Segmentation Plans For Obesity Treatment

 

As competition heats up and the obesity market matures, the two frontrunners are tailoring their studies to the wants and needs of different patient groups.

Vertex Heralds ‘Unprecedented’ Zimislecel Type 1 Diabetes Data

 
• By 

The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.

Pipeline Watch: Ten Approvals And Seventeen 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.