J&J eyes US nod for Caplyta in bipolar mania after second trial win

Nov 10 (Reuters) – Johnson & Johnson said on Tuesday its drug Caplyta eased manic symptoms better than placebo in a second late-stage study of patients with bipolar I disorder, paving the way for a planned US regulatory filing.

• The trial tested a 42 mg daily dose of Caplyta against placebo over three weeks in adults with manic episodes, with or without mixed features, associated with bipolar I disorder

• Bipolar disorder affects an estimated 36 million people worldwide. Symptoms of mania, a defining feature of bipolar I disorder, can include grandiosity, decreased need for sleep, racing thoughts, distractibility and risk-taking behavior

• Mania scores in patients taking the drug dropped 3.7 points more than those on placebo, the company said, based on a standard rating scale. Improvement was seen as early as day three

• Nearly 44% of patients treated with Caplyta had at least a 50% improvement in mania symptoms, compared with about 24% on placebo

• The results follow positive findings from the first late-stage study of the drug for mania, and together will support a planned submission to the US Food and Drug Administration seeking approval for bipolar mania

• Caplyta is already approved in the US for bipolar depression, schizophrenia and certain cases of major depression

• UBS analysts had said in a September note that Caplyta could reach long-term peak sales above $5 billion, though they expect sales of about $4.3 billion by 2033

• J&J gained access to Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies last year to bolster its neuroscience business

(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)