Novartis much-anticipated new heart failure drug Entresto has been approved in the EU, providing a new treatment option for millions of patients.
Entresto (sacubitril and valsartan) has been cleared for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) and is dosed as a twice-daily tablet.
Around 3.5 million patients are diagnosed with HF every year in Europe, and there are around 15 million people living with the condition, with 50% of these dying within five years of diagnosis. Around half of all HF diagnoses involve patients with reduced ejection fraction.
Entresto’s entry into the market has been keenly anticipated as treatment for chronic HF has not seen any major advances for many years. The approval is backed by data from the PARADIGM-HF trial, which showed the drug cut cardiovascular deaths by 20% versus standard therapy based on the ACE inhibitor enalapril, while also reducing hospitalisations by 21% and all-cause mortality by 16%.
Meanwhile, Novartis gained a big boost for the new product after the Institute for Clinical and Economic Review (ICER) concluded it was both clinically effective and appropriately priced. Given, the huge eligible patient population, some analysts predict Entresto could eventually become a $5bn product
The approval by the European Commission comes four months after Entresto was given the go-ahead in the US, its first market. It has also been registered in Switzerland and Canada, and made around $16m in sales in the third quarter.
Sales to date have remained modest mainly because two-thirds of patients eligible for treatment with the drug in the US are under Medicare, and it has taken time for Entresto to be added to Medicare Part D formularies. Novartis has said it expects this situation to resolve within the next six months or so and that US sales will accelerate as EU countries come on-line.
The Entresto news comes hard on the heels of another important approval for Novartis – EU approval of two new indications for anti-inflammatory drug Cosentyx (secukinumab), another drug with multibillion dollar sales potential.