Shots:
- Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26
- Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6% vs 5.6%. In Study 503 (n=809), remission increased to 65.4%, complete remission to 44.1%, & sustained remission to 42.8% by study end, increasing steadily through Wks. 8 (28.6%), 16 (37.2%), & 24 (40.8%); results were consistent across all subgroups
- Also, Caplyta’s sNDA for the prevention of relapse in schizophrenia is submitted to the US FDA supported by the long-term safety & efficacy data
Ref: J&J | Image: J&J | Press Release
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