Groundbreaking Drug Launches
Budesonide/formoterol/glycopyrrolate (Breztri Aerosphere)
Mechanism of Action: Beta 2 adrenergic receptor agonists; Glucocorticoid receptor agonists; Muscarinic receptor antagonists Drug class: Small molecules Originator: Pearl Therapeutics Owner: AstraZeneca Indication: Chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) is a progressive lung condition caused by lung damage, leading to inflammation in the airways and restricted airflow. Common symptoms include difficulty breathing, a daily cough with mucus, and wheezing. COPD is mainly caused by long-term exposure to irritants like cigarette smoke, fumes, dust, or chemicals. Emphysema and chronic bronchitis are the most common types, often occurring together and varying in severity. Chronic bronchitis involves inflammation of the bronchi, limiting airflow and increasing mucus production. Emphysema damages the alveoli, reducing oxygen absorption into the bloodstream. While COPD worsens over time, it is treatable. With proper management, people with COPD can control symptoms, improve quality of life, and reduce the risk of related conditions like heart disease and lung cancer.
Symptoms
COPD symptoms often don’t appear until significant lung damage has occurred and tend to worsen over time, especially if exposure to smoking or other irritants continues. Common symptoms of COPD include: • Shortness of breath, particularly during physical activities • Wheezing or whistling sounds when breathing • Persistent cough that produces mucus (which may be clear, white, yellow, or green) • Chest tightness or discomfort • Fatigue or lack of energy • Frequent lung infections • Unintended weight loss, which may occur as the condition progresses • Swelling in the ankles, feet, or legs
Prevalence
The prevalence of chronic obstructive pulmonary disease (COPD) varies by location and population. Here are some estimates:
Global: In 2020, the global prevalence of COPD was 10.6%, and it is projected to decrease slightly to 9.5% of the eligible population by 2050.
India: In India, 7% of people aged 30 and older are affected by COPD, with the highest prevalence in northern regions.
A Lung study of 8,569 individuals in India found an estimated COPD prevalence of 7.4%, with higher rates among males, urban populations, and those in northern India.
Treatment challenges in low- and middle-income countries (LMICs)
COPD represents a major global public health issue, with an estimated prevalence of around 10%. Low- and middle-income countries (LMICs) are disproportionately affected, contributing to approximately 85% of the global burden. Early childhood factors, poverty, and environmental influences have increasingly been recognized as key risk factors for COPD in these regions. The rise in COPD cases is expected to be particularly severe among females and in LMICs. In India, patients with COPD face several barriers to treatment, including limited access to medications, high costs, and misdiagnosis.
Challenges include: • Limited access to medications: Shortages of inhalers, oxygen therapy, and other treatments in LMICs. • High costs: The financial burden of medications and healthcare services is a challenge for patients and their families. • Misdiagnosis: Patients are often misdiagnosed, leading to delayed symptom recognition. • Inadequate healthcare: Limited training among healthcare providers. • Limited access to diagnostics: Restricted availability of essential diagnostic services.
Why is Budesonide/formoterol/glycopyrrolate poised to make an impact in 2025?
“Shares of AstraZeneca Pharma India increased by 2.98%, reaching Rs 6,588.35 per share on the Bombay Stock Exchange. This surge followed the company's announcement that it will launch Breztri Aerosphere in India in January 2025.”
AstraZeneca Pharma India had received approval from the Drugs Controller General of India for the import and marketing of Breztri Aerosphere in November 2024. The company also reported strong revenue growth in the second quarter of fiscal year 2024-25 (Q2FY25), with operational revenue rising by 31% year-on-year to Rs 408 crore. For the first half of FY25, revenue totaled Rs 795.5 crore, driven by strong performances in oncology, biopharmaceuticals, and rare disease sectors. The company’s stock has outperformed the market, climbing 16% year-to-date and 40% over the past year, while the BSE Sensex has gained 8.2% year-to-date and 18.8% over the last year.
The evolution of Breztri Aerosphere's market revenue in the past four years (2021-2024)
The data indicates that Breztri Aerosphere has consistently demonstrated higher market revenue over the past few years. This steady growth underscores the drug's strong market presence and the increasing demand for its respiratory benefits. Given this upward trend, it can be reasonably assumed that the launch of Breztri Aerosphere in India in 2025 will further drive its market revenue, potentially expanding its reach and influence in the Indian pharmaceutical landscape. With the approval and anticipated launch, the drug is poised to significantly impact the market, capitalizing on the growing need for advanced respiratory treatments.
“The 2025 launch of Breztri Aerosphere in India is expected to boost its market presence, capitalizing on growing demand for respiratory treatments”
Regulatory milestones
