AstraZeneca India, a science-led biopharmaceutical company, received Central Drugs Standard Control Organisation (CDSCO) approval to market its inhalation aerosol, a triple combination of budesonide (160 mcg), glycopyrrolate (9 mcg), and formoterol fumarate (4.8 mcg), the company said in an exchange filing on Thursday. The pressurised metered dose inhaler is recommended for the treatment and maintenance of patients with chronic obstructive pulmonary disease (COPD), the statement from the company informed.
COPD ranks as India's second leading cause of death, contributing to over 50 per cent of chronic respiratory diseases and standing as the third global cause of mortality. Symptoms include coughing, breathing difficulties, wheezing, and fatigue. COPD risk factors encompass smoking, sedentary lifestyles, and exposure to air pollution. Exacerbations not only harm the lungs but significantly elevate the risk of cardiovascular events during severe hospitalisations.
Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India added, “Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. The triple combination therapy has clinically demonstrated a significant reduction in the rate of moderate or severe exacerbations as compared with other available dual therapies. The indication improves lung function, helps with COPD symptoms and prevents flare-ups. We are also looking at the possibility of extending benefit towards the complete spectrum of respiratory disorders like chronic bronchitis, emphysema, or both.”
The company's statement further read, that in comparison to currently available dual therapies, this triple combination therapy is proven to considerably lower the rate of moderate to severe exacerbations, and mortality rates, and increase lung function. The inhalation aerosol is highly recommended for all patients with a history of multiple exacerbations.
Dr Sanjeev Panchal, Country President & Managing Director, AstraZeneca India, said, “COPD is probably an underprioritised disease around the world. In India, the government has already demonstrated its intent to manage COPD better by including it in the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS). With this approval, we are bringing science-based novel therapy to India and bridging access to better therapies that can transform outcomes for COPD patients. This approval is also a strong example of an innovative drug delivery technique that can target a common therapeutic challenge thereby reducing mortality as well as overall COPD disease burden.”
