US regulators have given the green light to AstraZeneca’s blockbuster Symbicort to be marketed for chronic obstructive pulmonary disease.
The Anglo-Swedish drugmaker says that the US Food and Drug Administration has approved Symbicort (budesonide/formoterol) for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. The thumbs-up is based on results from two Phase III trials, SHINE (six months) and SUN (12 months), which found that the combination respiratory drug significantly improved lung function within five minutes of the first dose and sustained that improvement for the duration of the studies.
Howard Hutchinson, AstraZeneca’s chief medical officer, said that more than 12 million Americans suffer from COPD and they now have “a new treatment option that can deliver long-term lung function improvement and daily symptom control, together with a rapid onset of action”. The approval will help the firm compete with GlaxoSmithKline’s combination drug Advair/Seretide (salmeterol and fluticasone), though the latter is well-established across the Atlantic for both asthma and COPD.
The agency’s go-ahead will boost sales of the drug which increased 29% to $514 million in the fourth quarter. The USA is an important market for the drug, seeing as how the European Patent Office revoked AstraZeneca’s patent for the use of Symbicort as a treatment for COPD in May last year.
