Johnson & Johnson Halts Phase III MACiTEPH Trial of Blockbuster Opsumit in Chronic Thromboembolic Pulmonary Hypertension

Sep 08, 2023 12:00 CST Updated 12:00

Johnson & Johnson

Medical Device R&D and Manufacturer

Johnson & Johnson's Subsidiary Janssen Announces Termination of MACiTEPH Phase III Trial for Opsumit (Macitentan) in Chronic Thromboembolic Pulmonary Hypertension

Johnson & Johnson stated in its announcement on Wednesday that no new safety signals were observed, while also noting that the interim results of MACiTEPH and its discontinuation "will not impact any of the company’s commercialized pulmonary arterial hypertension drugs."

Opsumit is a product that Johnson & Johnson acquired in 2017 after purchasing Actelion for $30 billion in cash. The active pharmaceutical ingredient of this drug is macitentan, a dual endothelin receptor antagonist that relaxes the pulmonary arteries and reduces blood pressure. In the United States and the European Union, Opsumit has been approved for the treatment of PAH (Pulmonary Arterial Hypertension). According to Johnson & Johnson's patent portfolio, Opsumit’s patent protection will expire in 2025.

Notably, Opsumit carries a black box warning regarding embryo-fetal toxicity. The label advises pregnant women not to take it.

Johnson & Johnson is continuing the indication expansion work for Opsumit, and the recent Phase III MACiTEPH study is only part of this effort. The company is also currently conducting the UNISUS Phase III study, which is evaluating a 75-milligram dose of Opsumit for the treatment of pulmonary arterial hypertension, compared to the currently approved 10-milligram formulation. Johnson & Johnson stated in a Wednesday announcement that the termination of MACiTEPH would not impact UNISUS.

Johnson & Johnson also proposed a combination regimen of Opsumit and tadalafil for the fixed-dose combination treatment of pulmonary arterial hypertension, and submitted a new drug application in May 2023.

Since joining Johnson & Johnson's portfolio in 2017, Opsumit has reached blockbuster status, generating $1.78 billion in net earnings for Johnson & Johnson in 2022. Despite a slight 2% decrease from nearly $1.82 billion in revenue in 2021, Opsumit remains the top-selling asset in Johnson & Johnson's pulmonary arterial hypertension business.

References:

1.https://www.biospace.com/article/j-and-j-terminates-phase-iii-study-of-blockbuster-opsumit-in-pulmonary-hypertension/

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