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AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval of a new indication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
London, UK | April 30, 2008 | AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval of a new indication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
The sNDA submission is based on results from two pivotal efficacy and safety trials with SYMBICORT pressurised meter dose inhaler (pMDI). Both studies were randomized, double-blind, parallel-group, multi-centre trials of patients (N=3,668) with moderate to very severe COPD. Results of the trials found SYMBICORT 160/4.5 (320/9 mcg bid) met the pre-specified co-primary endpoints and was found to be effective and well-tolerated for up to 12 months in patients with moderate to very severe COPD. Of note, both trials showed that SYMBICORT was well tolerated compared to the monoproducts budesonide and formoterol and placebo. The most common adverse events were bronchitis, oral candidiasis and nasopharyngitis, also known as the common cold.
“SYMBICORT is a combination maintenance treatment for patients with asthma that works rapidly to help improve lung function by reducing inflammation in the lining of the lung,” said Howard Hutchison, Chief Medical Officer, AstraZeneca. “We are confident in the data from the SHINE and SUN trials that support our submission, and we look forward to discussions with the FDA about this potential expanded indication.”
About COPD
More than 12 million people in the United States suffer from COPD, and it is the fourth leading cause of death in the nation. Some estimates also suggest that 12 million more people have COPD but are undiagnosed. COPD is a term referring to two serious lung diseases – emphysema and chronic bronchitis – that cause a person’s airways to become inflamed over time, making it difficult to breathe normally. Common symptoms include shortness of breath, chronic cough, wheezing and excess mucus. To reduce exacerbations and improve lung function and health status, the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) recommends the use of combination treatments with an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), in addition to other treatment options. COPD is a progressive disease, which means people with COPD can expect lung function to worsen over time. When symptoms are severe, it can be difficult for a person to perform simple, daily tasks and some people may eventually require supplemental oxygen and may have to rely on mechanical respiratory assistance.
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. Administered twice daily, SYMBICORT is a combination of two proven asthma medications – budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
SOURCE: AstraZeneca
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