J&J: stop the study evaluating macitentan 75 mg
(CercleFinance.com) - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced its decision to stop the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) due to futility.
The decision to stop the trial was made in accordance with a recommendation by the study's independent data monitoring committee following a pre-planned interim analysis. No new safety signals were observed.
The interim results of MACiTEPH do not impact any of the Company's commercialized pulmonary hypertension medicines. Additionally, the pivotal Phase 3 UNISUS study, which aims to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with pulmonary arterial hypertension, is currently continuing as planned.
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