FDA grants priority review to heart failure drug
FDA has granted priority review for LCZ696 (Novartis), an investigational drug for the treatment of heart failure with reduced ejection fraction (HFrEF).
FDA has granted priority review for LCZ696 (Novartis), an investigational drug for the treatment of heart failure with reduced ejection fraction (HFrEF).
LCZ696, a twice-daily drug, acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Currently available medicines for HFrEF only block the harmful effects and mortality remains very high, with up to 50% of patients dying within 5 years of a diagnosis of heart failure.
Related: Study: Too many heart failure patients are treated with IV fluids
Heart failure is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life.
It represents a major and growing health-economic burden that currently exceeds $30 billion in the United States, accounting for both direct and indirect costs. Hospitalizations account for 80% of the $21 billion spent on the direct costs of heart failure.
Related: New drugs raise hopes
The New Drug Application (NDA) is based on results from the landmark PARADIGM-HF study, which showed that LCZ696 was superior to the accepted guideline therapy ACE-inhibitor enalapril on key end points, including the primary end point, which showed reduction of the risk of either cardiovascular death or heart failure hospitalization by 20%.
The price of LCZ696 has not yet been established.
Read next: Study: Investigational drug may change course of patients’ heart failure
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
