AbbVie adds depression indication to Vraylar's label months after Gonzalez touts $4B+ peak sales potential
AbbVie CEO Richard Gonzalez wants to bring Vraylar to new heights. On Friday, regulators set the next phase of his plan in motion.
The FDA approved Vraylar, also known as cariprazine, as an add-on therapy for adults with major depressive disorder (MDD), one of the most common mental disorders in the US. That marks Vraylar’s fourth indication behind schizophrenia, the acute treatment of manic or mixed episodes in those with bipolar I disorder, and depressive episodes in bipolar I patients.
When AbbVie filed its supplemental new drug application (sNDA) back in February, Gonzalez predicted an indication in MDD would push peak sales past $4 billion. The drug earned $1.7 billion in 2021, comprising almost one third of AbbVie’s neuroscience revenue.
AbbVie’s now touting the drug as an option for patients who’ve made some progress on at least one other antidepressant — but no more than three — yet continue to suffer. About 1 in 5 adults will experience MDD in their lifetimes, according to AbbVie.
“Fifty or more percent of patients can have an inadequate response to their antidepressant, and those patients deserve more,” said Ken Kramer, associate VP and therapeutic area lead of psychiatry, US medical affairs at AbbVie.
Vraylar, initially co-developed by Allergan and Gedeon Richter, works by rebalancing dopamine and serotonin to improve mood and behavior. However, the path to approval hasn’t exactly been smooth.
At 6 weeks, patients on a 1.5 mg dose of Vraylar plus an antidepressant showed a statistically significant change from baseline in MADRS score, a common scale used to measure the severity of depressive episodes, compared to an antidepressant alone, according to AbbVie. However, a 3 mg dose of the drug missed statistical significance at 6 weeks, with a p-value of 0.0727. In a second study, AbbVie reported a statistically significant change from baseline to week 8 in patients who took an antidepressant plus Vraylar doses between 2 and 4.5 mg daily (with a mean dose of 2.6 mg).
AbbVie submitted an sNDA based on the “totality” of the data, and reaffirmed its confidence in the drug earlier this year. Patients taking Vraylar for MDD will start on 1.5 mg per day, and can move up to 3 mg a day after a couple weeks if necessary.
That wasn’t cariprazine’s first snag in late-stage development. Allergan and Gedeon Richter reported a Phase III flop in depression back in 2016. And in 2017, the FDA issued Allergan a refuse-to-file letter on its supplemental application for cariprazine as a new therapy for negative symptoms associated with schizophrenia. At the time, the drug had already been approved for schizophrenia and the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder.
However, AbbVie clearly likes what it sees. The pharma giant extended its collaboration with Gedeon Richter back in March, which will include “several new chemical entities.”
A 30-day supply of Vraylar costs just over $1,300. However, AbbVie said certain commercially insured patients can get their first two 30-day refills for free — and 30- or 90-day refills for as low as $5 — through its VRAYPAY program.
Vraylar isn’t approved for patients with dementia-related psychosis. When asked whether AbbVie plans to pursue an expanded label for pediatric patients with MDD, Kramer said it’s “still being determined.”
“It is a highly stigmatizing disease state,” Kramer said. “If you think about it, there’s no stigma if you have high blood pressure. There’s no stigma if you have macular degeneration in your eye. But there’s tremendous stigma when it comes to patients who are living with mental illness. And we, a very long time ago, decided that we were going to stay in this area because these patients deserve the best potential to live the lives they deserve.”