Allergan, badly in need of good news, finally has some to share with investors.
On Tuesday, the FDA greenlighted the company’s antipsychotic med Vraylar to treat depression in adults with bipolar disorder. The OK makes the drug the first of its kind to treat the full spectrum of symptoms in bipolar I, one of four main types of the mood-shifting disease.
And that’s an important distinction, influential doctors have told SVB Leerink’s Marc Goodman. “Having a product with a label across all of bipolar manic, mixed, and depressive episodes could differentiate Vraylar from other antipsychotics, as it simplifies the treatment approach and no longer requires physicians to split hairs and try to define patients as one type of bipolar disorder episode versus another,” he wrote in a note to clients.
The go-ahead comes on the back of three pivotal trials showing six weeks of Vraylar beat placebo at easing depression symptoms, as measured by the Montgomery Asberg Depression Rating scale.
While the FDA nod was “generally expected,” it’s “still important,” Credit Suisse analyst Vamil Divan wrote in his own note to clients. Allergan’s execs have said the label update could double Vraylar’s sales potential, taking the product well above the $487 million it recorded in 2018. Divan and his team, for their part, expect to see the drug rake in $1.16 billion in 2026.
And Allergan can certainly use a boost in the CNS department. The company recently reported a double phase 3 flop for closely watched candidate rapastinel in major depressive disorder.
“We are deeply disappointed with these results, and they are a vivid reminder that drug development is extremely challenging, especially in mental health,” David Nicholson, Allergan’s R&D chief, said in a statement at the time.
That setback was one of many to hit the drugmaker over the last couple of years. Restasis patent woes, serious Botox competition and asset-sale struggles have sunk shares, prompting unrest from activist investors and pledges from management for urgent action.