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Novartis acute heart failure med fails Phase 3

March 22, 2017

Novartis AG (NVS) has announced that its key drug RLX030 (serelaxin) intended for treating patients with acute heart failure has failed in a phase 3 study.

Drug Fails Both Trial Endpoints

The late stage trial involved 6,600 patients and was evaluating RLX030, when added to standard care, for its efficacy, safety and tolerability in treating patients with acute heart failure (AHF). The trial was aiming to achieve two primary endpoints – first, a reduction of cardiovascular (CV) death through day 180, and second, an occurrence of worsening heart failure through Day five. The drug failed to meet both.

Heart failure occurs when the heart fails to pump sufficient blood to meet the body’s demand and often leads to a heart attack. AHF is an emergency condition which occurs suddenly, is usually accompanied by severe breathlessness, and needs urgent treatment. Patients above 65 years of age are prone to the deadly condition, which has a high mortality rate of 20%.

Novartis has announced it will further analyze the trial data, and the future of the drug program will be decided based on the analysis.

Novartis’ Other Cardiovascular Drugs

The news comes on the back of successful results reported for the company’s other heart failure drug Entresto (sacubitril/valsartan), which showed better performance compared to the old established drug Enalapril that was approved in 2013.

Along with Entresto, Novartis has another lead candidate, ACZ885 (canakinumab), which is being evaluated in a phase 3 study in patients with a previous heart attack and a high degree of vascular inflammation. The trial data is expected later this year.

Earlier this week, a new class of diabetes drugs called SGLT-2 inhibitors was found to reduce risks of death and hospitalization for heart failure in diabetes patients. The drugs include AstraZeneca PLC’s (AZN) Farxiga (dapagliflozin), Eli Lilly & Co. (LLY) and Boehringer Ingelheim’s Jardiance (empagliflozin), and Johnson & Johnson’s (JNJ) Invokana (canagliflozin).


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