Key insights
- The FDA approved an expanded label for Johnson & Johnson's Caplyta for schizophrenia relapse prevention. Clinical trial data showed a significant reduction in relapse risk compared to placebo. The safety profile remained consistent with previous data. This positive development could lead to increased revenue for JNJ, but the overall market impact is limited.
Investing.com -- Johnson & Johnson (NYSE:JNJ) announced Monday that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Caplyta based on long-term data evaluating the drug’s safety and efficacy for the prevention of relapse in schizophrenia.
Schizophrenia affects approximately 2.8 million adults in the United States, with roughly 40 percent of individuals not receiving adequate care. Adults living with schizophrenia experience nine relapse episodes on average within a six-year period. The societal cost of schizophrenia in 2024 was estimated at $366.8 billion in the U.S.
In the Phase 3, double-blind, randomized withdrawal trial, Caplyta significantly extended time to relapse versus placebo during the 26-week double-blind treatment period. Patients who received Caplyta had a 63 percent lower risk of relapse compared with placebo, and 84 percent of patients were relapse-free over six months. Caplyta also significantly delayed time to all-cause treatment discontinuation, including relapse.
The safety profile remained consistent with the existing body of clinical data, and no new safety concerns were identified. The most common treatment-related adverse event was headache, which occurred in at least 5 percent of patients and at least twice the rate of placebo.
In schizophrenia short-term clinical studies, Caplyta was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms. In the Phase 3, 6-month randomized withdrawal, double-blind, placebo-controlled study, there were no clinically relevant increases in prolactin or cardiometabolic parameters at the end of the double-blind treatment period.
Long-term data from a 12-month open-label extension study in schizophrenia showed that patients treated with Caplyta experienced a mean weight change of –2.05 kg over one year, with sustained improvements or stability in metabolic parameters.
Caplyta is FDA approved in adults as an adjunctive therapy with antidepressants for major depressive disorder, schizophrenia, and depressive episodes associated with bipolar I or II disorder, as monotherapy, and as adjunctive therapy with lithium or valproate.
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