Orenitram (treprostinil; United Therapeutics) is a novel formulation of the prostacyclin analog treprostinil, formulated using Supernus Pharmaceuticals’ drug delivery technology, allowing for twice-daily oral dosing. Orenitram represents the continuation of United Therapeutics’ PH portfolio, led by intravenous Remodulin.
Although Orenitram (treprostinil; United Therapeutics) was approved as the first oral prostacyclin analog in the US, addressing an important unmet need of the time, its clinical data are weak and consequently the drug has only made a minor impact on the pulmonary hypertension (PH) market. Moreover, newer brand Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku) poses tough competition in the oral prostacyclin class. To better position its brand, United Therapeutics is investigating Orenitram’s potential in PH associated with left heart disease (PH-LHD) and aiming to use morbidity evidence from the FREEDOM-EV study that could support EU approval. While United Therapeutics is investing in further developing Orenitram, Datamonitor Healthcare ultimately does not foresee Orenitram outcompeting Uptravi as the former’s clinical profile is unconvincing. Nevertheless, Orenitram is still expected to indirectly benefit from the TRITON trial investigating the value of triple combination therapy with an oral prostacyclin
LIST OF FIGURES
12 Figure 1: Orenitram for pulmonary hypertension – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Orenitram for pulmonary hypertension
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Orenitram for pulmonary hypertension
17 Figure 4: Orenitram sales for pulmonary hypertension across the US and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Orenitram drug profile
7 Table 2: Orenitram pivotal trial data in pulmonary hypertension
9 Table 3: Orenitram late-phase data in pulmonary hypertension
11 Table 4: Orenitram ongoing late-phase trials in pulmonary hypertension
18 Table 5: Orenitram sales for pulmonary hypertension across the US and five major EU markets, by country ($m), 2016–25
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