Adempas (riociguat; Bayer/Merck & Co) is a first-in-class drug that activates soluble guanylyl cyclase (sGC), a key enzyme in nitric oxide-mediated vasodilation of vascular smooth muscle cells. In pulmonary hypertension, the production of nitric oxide is reduced; Adempas directly stimulates sGC’s enzymatic activity and increases the enzymes’ sensitivity to nitric oxide, leading to increased vasodilation of the pulmonary arteries.
Adempas (riociguat; Bayer/Merck & Co) is the only drug approved for both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), after completing separate pivotal clinical trials in both indications. Despite being approved for an underserved patient population, Adempas’s sales have not reflected this opportunity. A contributing factor may be the high rates of off-label use across the treatment paradigm. Furthermore, Datamonitor Healthcare perceives that the wider market trend towards combination use will continue to inadvertently push Adempas aside in the treatment algorithm, as the drug is contraindicated for use in combination with phosphodiesterase 5 (PDE5) inhibitors. Thus, Bayer and Merck & Co may rely on trials that position Adempas as an alternative treatment for those with inadequate responses to PDE5 inhibitors. The companies would do well to evaluate Adempas’s use for CTEPH in combination with Opsumit (macitentan; Johnson & Johnson/Nippon Shinyaku) to capitalize on this trend and to leverage the potential threat of competition from Opsumit for CTEPH into an opportunity.
4 Drug Overview
5 Product Profiles
5 Adempas : Pulmonary hypertension
LIST OF FIGURES
13 Figure 1: Adempas for pulmonary hypertension – SWOT analysis
14 Figure 2: Datamonitor Healthcare’s drug assessment summary of Adempas for pulmonary hypertension
15 Figure 3: Datamonitor Healthcare’s drug assessment summary of Adempas for pulmonary hypertension
17 Figure 4: Adempas sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Adempas drug profile
7 Table 2: Adempas pivotal trial data in pulmonary hypertension
10 Table 3: Adempas late-phase trial data in pulmonary arterial hypertension
12 Table 4: Adempas ongoing late-phase trials
18 Table 5: Adempas sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country ($m), 2016–25
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