AstraZeneca gets CDSCO approval to market its triple drug combination inhalation aerosol for treating COPD

New Delhi: AstraZeneca India has 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 pressurized metered dose inhaler is recommended for the treatment and maintenance of patients with chronic obstructive pulmonary disease (COPD).

COPD is the second leading cause of death in India, accounting for more than 50% of chronic respiratory diseases. It is the third leading cause of death worldwide. Coughing, difficulty breathing, wheezing, and fatigue are the symptoms of the disease. Smoking or using tobacco in any form, sedentary lifestyle choices, and air pollution are all risk factors for COPD. The damage from exacerbations due to COPD extends beyond the lungs. The risk of a cardiovascular event rises dramatically during a severe hospitalised exacerbation.

In comparison to currently available dual therapies, this triple combination therapy is proven to considerably lower the rate of moderate to severe exacerbations[2], mortality rates[3], and increase lung function. The inhalation aerosol is highly recommended for all patients with a history of multiple exacerbations.

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.”

Dr. Sanjeev Panchal, Country President & Manging Director, AstraZeneca India, said, “COPD is probably an underprioritized disease around the world. In India, government has already demonstrated its intent to manage COPD better by including it in 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 innovative drug delivery technique that can target a common therapeutic challenge thereby reducing mortality as well as overall COPD disease burden.”