Originally developed by Actelion, Johnson & Johnson’s Opsumit (macitentan) is the follow-on product to the leading pulmonary hypertension therapy Tracleer. The drug is a next-generation endothelin receptor type A and B antagonist.
Opsumit (macitentan; Johnson & Johnson/Nippon Shinyaku) is set to become the market leader with forecast peak sales of $2.2bn in 2025 across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK). Opsumit is the successor to Johnson & Johnson’s endothelin receptor antagonist (ERA) Tracleer (bosentan). While the drug still requires monitoring of liver enzymes, it does not share the same black box for hepatotoxicity as Tracleer. Additionally, Opsumit has importantly demonstrated efficacy in terms of delaying disease progression to complement efficacy in terms of six-minute walking distance. Given that generic bosentan is available in different markets, Opsumit does face pricing pressure, but it is less costly than Tracleer and may obtain a broader label. Opsumit may be able to secure approval for chronic thromboembolic pulmonary hypertension (CTEPH) and pediatric pulmonary arterial hypertension (PAH). By encouraging switching from Tracleer to Opsumit, Johnson & Johnson may retain significant market share with its new standard-of-care therapy and continue to benefit from increasing adoption of ERAs in combination regimens.
Opsumit : Pulmonary hypertension
LIST OF FIGURES
Figure 1: Opsumit for pulmonary hypertension – SWOT analysis
Figure 2: The authors drug assessment summary of Opsumit for pulmonary hypertension
Figure 3: Opsumit sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
Table 1: Opsumit drug profile
Table 2: Opsumit pivotal trial data in pulmonary hypertension
Table 3: Opsumit late-phase trial data in pulmonary hypertension
Table 4: Opsumit ongoing late-phase trials in pulmonary hypertension
Table 5: Opsumit sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country ($m), 2016–25