FDA approves Caplyta for bipolar depression in adults

22 December 2021

US biotech Intra-Cellular Therapies (Nasdaq: ITCI) saw its shares gain 6.3% to $48.20, after it revealed that the US Food and Drug Administration has approved Caplyta (lumateperone tosylate) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

This adds to the drug’s approval two year ago for the treatment of schizophrenia. Sales so far this year reached $56.2 million, but analysts at BTIG see the added indication offering much more commercial potential.

Data and analytics company GlobalData notes that the MDD market in the eight leading markets (8MM: the USA, France, Germany, Italy, Spain, UK, Japan and China is expected to reach $7.87 billion by 2029, up from $3.39 billion in 2019, with eight new pipeline products set to address the unmet needs of a growing patient population.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK