Abbott’s Once-A-Day Ivabradine Receives DCGI Approval for Heart Failure and Angina Patients

 

Summary

* Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina[1]

* It is estimated that 1.3 to 4.6 million people suffer from heart failure, with 0.5–1.8 million new cases per year in India[2]

* Formulation developed in Abbott’s Innovation and Development center in India based on physician insights on the need for a convenient dosing

* Abbott’s approval is based on data from a phase 3 clinical trial

The global healthcare company Abbott today announced that it has received approval from the Drugs Controller General of India (DCGI) for its Ivabradine, once-a-day formulation. For chronic conditions such as cardiac diseases in India, adherence to a treatment is typically low[3], and when medicines have to be taken multiple times a day, convenience becomes a key patient need. To address this unmet need for more convenient dosing, Abbott developed India’s first “once daily” prolonged release (PR) version of Ivabradine indicated for patients with chronic heart failure and chronic stable angina. This formulation will be more convenient for patients, which will help facilitate treatment adherence with the aim to improve health outcomes. Abbott plans to launch the Ivabradine PR tablets in the Indian market in the coming weeks.

In India, estimates of people with heart failure range between 1.3 and 4.6 million, with 0.5–1.8 million new cases recorded every year[4]. According to the Global Burden of Disease study, an estimated 14.4 million men and 7.7 million women have lost their productive years  to coronary heart disease-related disability[5].

While the burden of the disease is high in the country, non-adherence to treatment remains a key challenge. Studies have found that many people with cardiac disease in India don’t take their medicines as prescribed by their doctor and an AIIMS study estimates that non-adherence to medication ranges from 24% for people with cardiac disease to 50%-80% for people with hypertension .[6]

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 centers in India, the first of its kind to be conducted for this formulation, 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. J. Kannan, MD, DM, Cardiologist, Narayana Hrudayalaya, explains, “45% of patients suffering from heart failure have a high heart rate with about 40% being hospitalized. 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) center in Mumbai.  The I&D center is an important global innovation hub for Abbott’s  pharmaceutical business. Researchers at the I&D center use local insights to anticipate patient needs. These insights are linked with existing and innovative technologies to deliver meaningful innovation. Insights from physicians revealed the need for a simpler, more convenient dosing for Ivabradine, which led to the once-a-day solution.

Commenting on the new formulation, Abbott’s Regional Medical Director, Dr. Balagopal Nair, said, “Our goal is to improve health by enhancing medicines to meet patients’ unmet medical needs. Adherence to therapy is a critical factor to maximize the overall health of people with chronic heart failure or chronic stable angina. 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.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries. In India, Abbott was established in 1910, and is one of the country's oldest and most admired healthcare companies. With over 12,000 employees in the country, Abbott in India is helping to meet the healthcare needs of consumers, patients and doctors throughout urban and rural India.