NOVARTIS, SERELAXIN (RLX-030) in Acute Heart Failure – Significant Mortality benefit and unmet need would allow better commercial opportunity
Novartis released final outcome data from Phase-3 study (RELAX-AHF) exploring Serelaxin in Acute Decompensated Heart Failure patients at AHA. Although RLX-30 demonstrated a 37% statistically significant reduction mortality risk, there is criticism around the strength of this evidence. As the total mortality events were less on an absolute basis, if the number of deaths is reduced by two in each arm the benefit looses statistical significance. It seems the regulator may ask for a larger trial, but looking at the unmet need in Acute decompensated Heart failure, an accelerated approval is very much possible. We project a minimal peak sales of $600million for Serelaxin, and depending on the extent of mortality benefit proved in another PhIII study, the compound can gross close to blockbuster sales.
