China approves Bevespi Aerosphere for patients with COPD

Shares of AstraZeneca (LSE: AZN) were up 1.55% at £88.05 by late morning, after it revealed that its Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval by China’s National Medical Products Administration (NMPA) was based on positive results from the Phase III PINNACLE 4 trial in which Bevespi Aerosphere demonstrated a statistically-significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components and placebo, all administered twice daily via pressurized metered-dose inhaler (pMDI) in patients with moderate to very severe COPD. The trial formed part of the broader PINNACLE clinical trials program showing efficacy and safety and involving more than 5,000 patients across Asia, Europe and the USA.

This was the first approval by the NMPA for a maintenance, fixed-dose, long-acting dual bronchodilator combination therapy in a pMDI, which uses the innovative Aerosphere delivery technology, according to AstraZeneca.