Reasanz has the potential to fill a substantial unmet need within ADHF.
By Louisa Joseph, Analyst
24 March 2016
Reasanz has demonstrated favorable effects in the RELAX-AHF trial, but will need to reconfirm these positive results in a larger Phase III trial in order to gain approval in ADHF.
Datamonitor Healthcare surveyed 218 cardiologists across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) to calculate the ADHF treatment population and to gain an understanding of current and future prescribing patterns in ADHF. In the Phase III RELAX-AHF trial, Reasanz demonstrated beneficial effects on dyspnea and other early targets of ADHF treatment, as well as an overall reduction in mortality at 180 days. The reduction in all-cause and cardiovascular (CV) mortality generated the most interest among heart failure experts, as Reasanz was the first drug to demonstrate a mortality benefit in the ADHF treatment setting. However, the US Food and Drug Administration (FDA) and the European Medicines Agency rejected Reasanz for the treatment of ADHF due to a lack of compelling trial data. Both regulatory bodies raised concerns about the interpretation of the main primary endpoint of the RELAX-AHF trial – relief in dyspnea – and concluded that the trial was underpowered to confirm mortality results.
For this reason, Reasanz is currently being investigated in a larger Phase III outcomes trial, RELAX-AHF-2, which has been designed with mortality as the primary endpoint. Datamonitor Healthcare recognizes that Reasanz will need to reconfirm its effects on dyspnea and/or demonstrate a true impact on overall mortality in the RELAX-AHF-2 trial in order to gain approval in ADHF.
Reasanz sales for acute decompensated heart failure in the US ($m)
Source: Datamonitor Healthcare’s ADHF forecast, March 2016
Datamonitor Healthcare’s ADHF forecast covers the expected impact of newly branded therapies on the highly genericized ADHF market, as well as a detailed look at the current ADHF pipeline.
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