Abbott gets DCGI approval for Ivabradine

Abbott has received approval from the Drugs Controller General of India (DCGI) for its Ivabradine, once-a-day formulation.

Abbott developed India’s first “once daily” prolonged-release (PR) version of Ivabradine indicated for patients with chronic heart failure and chronic stable angina. Abbott plans to launch the Ivabradine PR tablets in the Indian market in the coming weeks.

With its new formulation, Ivabradine PR tablets can be prescribed as a once-a-day medicine compared to the multiple dosing generally required by patients for the management of the disease. A phase 3 clinical study conducted by Abbott across 21 centres in India, showed Ivabradine PR once-a-day formulation to be comparable with the conventional Ivabradine twice-a-day, in the management of patients with stable chronic heart failure, with comparable efficacy and safety profile.

Talking about Ivabradine as a therapy for heart failure patients, Dr Bharat Chanana, MD, DM CARD, Maharaja Agrasen Hospital explains, “45 per cent of patients suffering from heart failure have a high heart rate with about 40 per cent being hospitalised. The new once-daily formulation of Ivabradine will facilitate patient adherence to treatment by reducing the pill burden. This will help control their heart rate and thus reduce hospitalization and improve quality of life.”

This formulation has been developed at Abbott’s Innovation & Development (I&D) centre in Mumbai.

Commenting on the new formulation, Abbott’s Regional Medical Director, Dr Balagopal Nair, said, “We have used the best technology and science to develop this new dosage formulation. The convenient once-a-day formulation will help improve overall treatment adherence, leading to better health outcomes.”

Chronic heart failure is a progressive condition in which the heart is unable to pump sufficiently to maintain blood flow to meet the body’s demands for oxygen. Chronic stable angina usually occurs due to obstruction or spasm of the arteries that supply blood to the heart muscle. Ivabradine helps maintain a stable heart rate and prevent it from spiking, which is an important prerequisite in reducing symptoms and in improving the prognosis of both conditions.