The goals of treatment for chronic heart failure (HF) are to relieve symptoms, prevent HF-associated hospitalizations, slow disease progression, and improve survival. The current therapies in the market are well-established. Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta blockers are all used within the HF landscape regardless of type of HF. All these drugs have clinical limitations. There is strong opportunity in this disease space for new agents such as Novartis’ Entresto that could further reduce the incidence of HF-associated hospitalizations and mortality, says GlobalData, a leading data and analytics company.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: “If Entresto (sacubitril/valsartan) receives approval, it will be the first therapy to be approved for symptomatic chronic HF for patients ages one year and older in the EU. This is significant because among pediatric patients, up to 33% of cardiac hospital admissions are associated with HF.”

Novartis recently announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Entresto for pediatric patients ages one year and older with symptomatic chronic HF.

Jaddoo continues: “The CHMP’s positive opinion will likely shed light on Entresto’s ability to provide children with HF with an age-appropriate drug formulation, enabling accurate and convenient drug administration. Key opinion leaders interviewed by GlobalData have stated that a big issue among HF patients is that they do not receive therapy at the optimal doses, leaving them under-dosed.”

The positive CHMP recommendation is based on data from Phase III programs. Entresto was seen as a revolutionary advancement in the HF field due to its demonstrated efficacy in the Phase III PARADIGM-HF trial in reducing the number of deaths due to cardiovascular causes, HF hospitalizations, and all-cause mortality compared to angiotensin-converting enzyme inhibitors.

The Phase III PANORAMA-HF trial was the largest trial for pediatric HF. The trial showed reduced N-terminal pro-brain natriuretic peptide, elevated levels of which cause reduced pumping capacity in the heart and increased severity of HF.

Jaddoo concludes: “Entresto’s potential approval for use in pediatric patients is a significant milestone in the treatment of symptomatic chronic heart failure. Novartis is expected to see a significant boost in its revenues if the drug receives approval from the European Commission.”