AstraZeneca intends to send applications for the approval of Bevespi Aerosphere (glycopyrronium / formoterol fumarate) to regulatory authorities in Japan and China.
This drug is intended for the treatment of moderate and severe forms of chronic obstructive pulmonary disease (COPD).
COPD is a lung disease in which human breathing is difficult. This is due to damage to the lungs for many years, most often from smoking. As a rule, COPD combines two diseases: chronic bronchitis and emphysema.
The double bronchodilator is approved in the US as a long-term maintenance therapy for breathing disorders in COPD. Now the registration application for Bevespi Aerosphere is being considered in Europe.
According to the results of the Phase III clinical trial of PINNACLE 4, Bevespi Aerosphere showed a significant improvement in lung function compared to the components of the drug as monotherapy and placebo, which were applied twice a day through a metered aerosol inhaler.
After approval for the drug of the Swedish-British pharmaceutical company, bright opportunities will open in the densely populated Asian market.