AbbVie advances major depressive disorder ambitions for Vraylar with hopes for $4B-plus in sales

AbbVie’s Allergan-acquired antipsychotic medicine Vraylar is already going gangbusters in its two approved indications. An expansion into tough-to-treat depression, meanwhile, would only build on the med’s multibillion-dollar trajectory.

AbbVie sent off an FDA application for schizophrenia and bipolar drug Vraylar as an add-on treatment for patients with major depressive disorder (MDD) who are already on antidepressants. A green light could help propel the blockbuster beyond an expected $4 billion in peak sales, AbbVie executives said on a recent call with investors.

AbbVie based its filing on results from a pair of late-stage studies. In the phase 3 trial 3111-301-001, Vraylar showed a statistically significant change from baseline to Week 6 on a standard depression rating scale versus placebo. In the registration-enabling study RGH-MD-75, a higher dose of Vraylar also bested placebo, showing a statistically significant change from baseline to Week 8 on the same depression rating scale.

“In both of these studies, safety data were consistent with the established safety profile of cariprazine across indications, with no new safety events identified,” AbbVie said in a release. Cariprazine is Vraylar’s generic moniker.

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The company’s submission also leveraged a third study, RGH-MD-76, which examined the safety and tolerability of Vraylar over 26 weeks.

"Many people living with major depressive disorder struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment,” Michael Severino, M.D., vice chairman and president of AbbVie, said in a statement. “Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms.”

MDD is one of the most common mental disorders in the U.S., AbbVie notes. In 2020, an estimated 21 million adults had at least one major depressive episode, the company said in its release. Meanwhile, the World Health Organization lists depression as the third-leading cause of disability worldwide plus a major contributor to the overall global burden of disease.

Vraylar, for its part, is already approved in the U.S. to treat adults with schizophrenia or depressive, acute manic and mixed episodes linked to bipolar 1 disorder.

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“Vraylar continues to have a significant opportunity with currently approved indications, with peak sales expected to approach $4 billion,” AbbVie CEO Rick Gonzalez said earlier this month on the company’s fourth-quarter earnings call. “An approval in major depressive disorder represents upside to our current projections,” the CEO added.

For 2021, Vraylar generated just over $1.7 billion. The drug is expected to reach sales of about $2.2 billion in 2022, Pharmaphorum reports.

If approved in MDD, Vraylar would compete with Johnson & Johnson’s Spravato (esketamine). The drug scored its first approval in 2019 to treat depression patients who had tried at least two other antidepressants. Then, in September 2020, Spravato won a new FDA green light to treat depressive symptoms in adults with major depressive disorder with acute suicidal thinking or behavior.