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Home Industry News Novartis ends heart failure trial early due to positive results

Novartis ends heart failure trial early due to positive results

2nd April 2014

Novartis has announced an early end to PARADIGM-HF, a phase III trial assessing the benefits of LCZ696, its new treatment for heart failure.

An independent data monitoring committee has unanimously recommended early closure of the study, based on interim results showing patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalised than those receiving standard care with the ACE-inhibitor enalapril.

This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable, meaning the primary goals of the study have already been met.

Novartis will now initiate discussions with global health authorities regarding approval for the drug, which it hopes can become a new cornerstone in the management of chronic heart failure.

Tim Wright, global head of development at Novartis Pharmaceuticals, said: "Novartis recognises the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696's unique mechanism of action could be transformative."

This comes after the firm announced the publication of clinical data last week that demonstrated the benefits of LDK378, a treatment for ALK-positive non-small cell lung cancer.ADNFCR-8000103-ID-801709102-ADNFCR

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