Dr. Frank Casty, Executive Director, Respiratory and Inflammation at AstraZeneca confirmed that the development of Pulmicort Respules underscores the company's commitment to provide novel treatments for paediatric asthma. "Now with the approval of Pulmicort Respules, physicians and parents will have an important new therapy to help them manage paediatric asthma and reduce the symptoms associated with this disease," said Dr. Casty. Pulmicort Respules is a preventative medication that helps control asthma in infants and children from 12 months to eight years of age.
The FDA approval of Pulmicort Respules is based on data from three 12-week double-blind U.S. clinical studies involving 946 children 12 months to eight years of age with mild to moderate persistent asthma. Pulmicort Respules reduced the need for bronchodilators and improved the control of night and daytime asthma symptoms.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.
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Steve Brown
+44 (0)20 7304 5033
Lucy Williams
+44 (0)20 7304 5034
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- Asthma is the most common chronic paediatric disease. Its prevalence among children is increasing worldwide. In the U.S., asthma affects nearly five million children with as many as 80% demonstrating symptoms before the age of five.
- Pulmicort Respules has been marketed around the world since 1990 and is now available in 55 countries. Its active compound, budesonide, has been used for over 15 years in various anti-asthma formulations worldwide. Pulmicort Turbuhaler (budesonide inhalation powder) was launched by AstraZeneca as the first dry-powder, CFC-free corticosteroid inhaler in the U.S. in 1998.
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