Intra-Cellular scores another FDA nod for Caplyta, this time for bipolar disorder

The FDA is making a habit of delivering Intra-Cellular Therapies an early Christmas present.

Two years ago, on Dec. 23, the U.S. regulator approved Intra-Cellular’s first product, Caplyta, for schizophrenia. Monday, the FDA expanded Caplyta’s label, endorsing it for bipolar depression.

This nod carries more weight as Caplyta becomes the only approved treatment for depressive episodes associated with bipolar I or II disorders in adults as both a monotherapy and as adjunctive therapy with lithium or valproate.

Bipolar I and bipolar II affect approximately 11 million adults in the U.S. and are characterized by recurring episodes of mania (highs) interposed with episodes of major depression. Bipolar I and bipolar II, which is milder, each account for half of people with bipolar disorder.

RELATED: Intra-Cellular nabs nod for schizophrenia drug Caplyta after FDA twists and turns

The latest approval is based on phase 3 studies that evaluated Caplyta as a monotherapy and as a combo treatment with lithium or valproate. In both trials, by Week 6, the treatment demonstrated significant improvements over placebo from baseline in the Montgomery-Asberg Depression Rating scale.

At 42 mg, the dosage matches that for Caplyta’s schizophrenia indication.

RELATED: Intra-Cellular's Caplyta could cruise toward blockbusterland with bipolar depression win: analyst

Caplyta generated $22.5 million in sales during the nine months it was on the market in 2020. So far this year, it has pulled in $56.2 million. With this approval, however, analysts at BTIG see much more commercial potential.

“We expect a significant acceleration of revenue growth beginning in early 2022,” Robert Hazlett of BTIG wrote in a note to clients.

In September of 2020, after trial results were unveiled, Brian Abrahams of RBC Capital Markets said Caplyta’s efficacy compared “reasonably well” with Allergan’s Vraylar and Sunovion’s Latuda. The analyst said the safety of Intra-Cellular’s treatment was an “important differentiator" in driving Caplyta’s commercial success.