AstraZeneca submits sNDA for SYMBICORT for COPD treatment
Dated: 5/7/2008
AstraZeneca has 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 (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.
