AbbVie adds to Vraylar data as FDA considers depression use

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AbbVie has reported new phase 3 data for its schizophrenia and bipolar disorder therapy Vraylar in treatment-resistant depression, as it waits for a decision by the FDA on the new indication.

The drugmaker filed Vraylar (cariprazine) as an add-on to conventional antidepressant therapy in people with MDD who may be struggling to control symptoms using the antidepressant alone in February, with a decision expected by the end of the year.

The updated results from Study 3111-301-001 show that after six weeks' treatment, the drug achieved the primary endpoint of a significant improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo in treatment-resistant depression.

The treatment effect was mixed however, as has been seen in other trials of the drug in this setting.

There was a significant effect at the lower 1.5mg/day dose of Vraylar, with 44% of patients treated at this dose achieving an MADRS response, but while a 3mg/day dose showed a trend towards improvement over placebo it did not clear the statistical threshold.

By the end of the follow-up period, around 39% of patients in the higher-dose group had an MDRS response, versus almost 35% in the placebo group, falling short of being an unequivocal success in the new indication.

The pattern was similar on other symptoms scales, including the Clinical Global Impressions-Severity Score and the Hamilton Depression Rating Scale, with only the 1.5mg dose showing a significant improvement.

AbbVie will be hoping that the dose-response anomaly in the results, which may be related to side-effect burden, won't undermine its bid to extend the uses of the fast-growing dopamine D2/D3 receptor partial agonist, one of the star assets to emerge from its $63 billion mega-merger with Allergan.

In its favour is the pressing need for new treatment options in people with severe MDD who don't respond to current therapies, with patients often switched between standards drugs in similar classes with little hope of improvement in therapy.

"We are pleased to present these data demonstrating cariprazine's potential to have an impact on patients as an adjunctive treatment of major depressive disorder," said Michael Gold, AbbVie's head of neuroscience development.

"The results from this study, along with previously reported data, served as the basis of our recent…submission to the FDA and further underpin AbbVie's commitment to advancing innovative psychiatric therapies for patients in need."

Vraylar is approved to treat schizophrenia and various aspects of bipolar disorder, including manic and depressive episodes, and despite setbacks on its way to market has become one of AbbVie's fastest-growing products with sales expected to reach around $2.2 billion this year, up from just over $1.7 billion in 2021.

AbbVie has previously said it expects the drug to reach $4 billion in peak sales from its current indications, not including any possible upside from an approval in treatment-resistant depression.