Last Updated on December 31, 2023 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO) has approved Boehringer Ingelheim’s Jardiance (empagliflozin) in India for the treatment of heart failure with preserved ejection fraction (HFpEF).
With this approval, Jardiance is now the first and only clinically-approved therapy to reduce the risk of cardiovascular death plus hospitalisation for heart failure, across the full spectrum of ejection fraction, a statement from Boehringer Ingelheim notified.
HFpEF is a form of heart failure which occurs when the heart muscle contracts normally, but the left ventricle does not fill up with enough blood, leading to less blood entering the heart compared to a normal functioning heart, the statement said.
It further said that Jardiance received approval for the new indication based on the EMPEROR-Preserved trial which revealed that empagliflozin (10 mg) reduces the risk of hospitalisation for heart-failure and cardiovascular death by 21 per cent, in adult patients of heart failure with mildly-reduced or preserved ejection fraction, with or without diabetes.
The benefits with Jardiance were demonstrated to be significant and meaningful, in patients of heart failure with mildly-reduced as well as preserved ejection fraction.
The new indication approval applies to eligible patients with HFpEF, regardless of their type-II diabetes status, and is an addition to the previously approved indications for glycemia control in type-II diabetes, as well as for reducing the risk of cardiovascular death plus hospitalisation for adults with heart failure with reduced ejection fraction (HFrEF), the statement added.
In February 2022, the US Food and Drug Administration (USFDA) approved empagliflozin 10 mg to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure.
In March 2022, Jardiance (empagliflozin) became the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction, according to the statement.
FAQs by CDSCO on Pharma, Cosmetics, MDR, Clinical Trial
Latest Circulars, Notices & Guidelines: CDSCO, DCGI
USFDA completes inspection of Aurobindo Pharma with no remaining deficiencies
Regulatory framework for Nutraceutical industry
Govt preparing roadmap for strengthening testing infrastructure for Medical Devices
Govt: Conduct due diligence on claims of local manufacturers of 67 Drugs
USFDA-Gujarat FDCA Regulatory Forum to be held from 17th to 19th May
Lupin, Glenmark, Dr Reddys recall these BP drugs
Indian Drug manufacturers and Exporters get 6-month time to export drugs to Nigeria
Govt Job: Drug Inspector (Ayurveda) under Public Service Commission
FAQs – on Schedule-P (Expiry Date of drugs)
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
