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Novartis gets USFDA nod for heart failure drug

Novartis India Country President Ranjit Shahani said the early approval by the USFDA, ahead of priority review date of LCZ696, will benefit many patients afflicted with heart failure.

July 10, 2015 / 07:59 IST
     
     
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    Drug firm Novartis has received nod from the US health regulator for its heart failure treatment tablets - LCZ696 - and the company plans to launch the medicine in India.

    Novartis India Country President Ranjit Shahani said the early approval by the USFDA, ahead of priority review date of LCZ696, will benefit many patients afflicted with heart failure.

    "Novartis India is working hard to bring this important treatment to Indian patients in a timely way," he added.

    The company plans to launch LCZ696 (sacubitril/valsartan) tablets under the brand name 'Entresto' in the US market. Shahani said the drug "reduces risk of death from cardiovascular causes by 20 percent and will offer these patients a much greater opportunity to live longer and stay out of hospital".

    The Swiss drug major said the USFDA's decision was based on results of a study on 8,442 patients, including 637 from India.

    Heart failure is a condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalisations and symptoms such as breathlessness, fatigue and fluid retention significantly impacting quality of life.

    first published: Jul 10, 2015 07:55 am

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