Symbicort gains COPD indication
pharmafile | March 4, 2009 | News story | Research and Development |Â Â SymbicortÂ
AstraZeneca's respiratory drug Symbicort can be used to help US patients with chronic obstructive pulmonary disease (COPD).
The FDA has approved the brand (budesonide/formoterol fumarate dihydrate) for the twice-daily relief of airflow obstruction.
The move brings AZ's drug into line with GSK's rival treament Seretide, which has had a US indication for COPD since 2003.
COPD is a catch-all term for a number of serious respiratory conditions, including emphysema and chronic bronchitis.
Both of these are serious lung diseases resulting in chronic inflammation of airways and progressive loss of lung function.
COPD is primarily caused by smoking and, at its worst, sufferers have difficulty in breathing normally.
"More than 12 million Americans struggle each day to live with the debilitating symptoms of COPD," said Howard Hutchinson, AstraZeneca's chief medical officer.
Symbicort, a corticosteroid/beta-2 agonist combination inhaler, is already approved for treating COPD in 91 countries worldwide.
A single inhaler provides the inhaled corticosteroid budesonide (Pulmicort) and the rapid and long-acting bronchodilator formoterol (Oxis).
Symbicort pMDI (pressurised metered-dose inhaler) has been available in the US since June 2007 for the treatment of asthma in patients over 12 years of age.
FDA approval for the COPD indication is based on two clinical trials: SHINE, which lasted six months, and the year-long SUN.
Both found Symbicort significantly improved lung function within five minutes of the first dose and sustained that improvement for the length of the trials.
"With the approval of Symbicort in COPD, patients have a new treatment option that can deliver long-term lung function improvement and daily symptom control, together with a rapid onset of action," said Hutchinson.
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