AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

As AbbVie inches toward its big loss of exclusivity for Humira in early 2023, the company will have an important launch to help offset the biosim erosion.

AbbVie's Vraylar, already a blockbuster, on Monday grabbed a coveted label expansion treat depression alongside an antidepressant therapy.

About half of the one in five adults in the U.S. who experience major depressive disorder still had depressive symptoms after treatment with their first antidepressant. For those patients, Vraylar offers a new treatment option.

The FDA approved the drug partly based on a phase 3 trial comprised of 751 patients in seven countries who had an “inadequate clinical response” to an antidepressant monotherapy. Investigators assessed the participants with the Montgomery-Asberg Depression Rating Scale (MADRS) and found that the drug delivered a statistically significant change from their baseline scores at week six.

The drug is also approved for schizophrenia and depressive, acute manic and mixed episodes associated with bipolar 1 disorder. While Vraylar’s mechanism of action is “unknown," AbbVie says, its efficacy is thought to be from a combination of partial agonist activity at central dopamine D2 and serotonin receptors.

When the company laid out its ambitions in this indication during last year’s fourth-quarter earnings call, CEO Rick Gonzalez said Vraylar's peak sales could eventually reach $4 billion. In 2021, Vraylar garnered sales just over $1.7 billion.

Major depressive disorder is a leading cause of disability worldwide; the estimated economic burden of the disorder in the U.S. was estimated to be around $326 billion in 2020.

The large patient population makes it a hot treatment market, especially with the rise in diagnoses thanks to the pandemic. A few months ago, Axome Therapeutics rolled out the first fast-acting oral MDD treatment, Auvelity. Then there’s Johnson & Johnson’s Spravato, an esketamine nasal spray that scored approval back in 2019.

As for AbbVie, this approval should provide a growth driver as megablockbuster Humira nears biosimilar competition. Starting next year, AbbVie's top drug will face competition from a handful of rivals.