AstraZeneca's COPD Treatment Gains Approval from CDSCO

This pressurised metered dose inhaler is designed for the treatment and maintenance of patients suffering from chronic obstructive pulmonary disease (COPD).

AstraZeneca Pharma India, a leading biopharmaceutical company has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its inhalation aerosol—a triple combination of budesonide, glycopyrrolate, and formoterol fumarate.

This pressurised metered dose inhaler is designed for the treatment and maintenance of patients suffering from chronic obstructive pulmonary disease (COPD).

COPD, the second leading cause of death in India, constitutes over 50% of chronic respiratory diseases and is the third leading cause of death globally.

In contrast to existing dual therapies, triple combination therapy has proven efficacy in significantly reducing the rate of moderate to severe exacerbations and mortality rates and enhancing lung function. It is particularly recommended for patients with a history of multiple exacerbations.

Commenting on the same, Dr Anil Kukreja, vice-president of Medical Affairs and Regulatory, AstraZeneca India, said, "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 compared to other available dual therapies."

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas - oncology, cardiovascular, renal & metabolism, and respiratory.

Established in 1979, in India, the company aims to deliver life-changing medicines to patients through innovative science and global excellence in development.

Recently, AstraZeneca's rare disease unit Alexion bought Pfizer Portfolio. It signed a licence and purchase agreement for a rare disease programme portfolio from Pfizer Inc. The acquisition of a preclinical rare disease gene therapy programme portfolio from Pfizer is reported to be approximately $1 billion.

Also, AstraZeneca India's recent CDSCO approval for palivizumab, a preventive therapy for Respiratory Syncytial Virus (RSV), is noteworthy. RSV is a significant global public health concern and the second most common cause of death in children under the age of one.

In related developments, CDSCO's recent approvals include the CAR T-cell therapy for leukemia and refractory or relapsed lymphoma. Additionally, CDSCO sanctioned nine medical device testing laboratories across India, aligning with the guidelines specified in Form-MD-40 under the MDR, 2017.

Looking ahead, the CDSCO is set to establish a Digital Drugs Regulatory System (DDRS) to streamline regulatory activities for drugs, medical devices, cosmetics, and more. The DDRS aims to consolidate existing portals, providing a unified digital ecosystem for regulatory processes and fostering trust in healthcare product quality domestically and globally.