Tags : Bevespi Aerosphere

Biotech Regulatory

AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate) Receives NMPA’s Approval for Patients

Shots: The NMPA’s approval is based on P-III PINNACLE 4 study assessing Bevespi Aerosphere (bid via a pMDI) vs its monotherapy components (glycopyrronium and formoterol fumarate) and PBO in patients with moderate to very severe COPD The P-III PINNACLE 4 study demonstrated improvement in lung function as measured by trough forced expiratory volume in one […]Read More


AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study

Shots: The P-III ETHOS study involves assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) vs Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg) in symptomatic patients with mod. to sev. COPD The P-III ETHOS study resulted in meeting its 1EPs i/e, reduction in the rate of mod./sev. exacerbations at both standard & half dose of budesonide. […]Read More


AstraZeneca’s Breztri Aerosphere (PT010) and Bevespi Aerosphere Receive MHLW’s Approval

Shots: The approval of Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate) is based on P-III KRONOS study results assessing PT010 vs Bevespi Aerosphere & PT009 in patients with COPD, resulted in improvement in trough forced expiratory volume in one second (FEV1) The approval of Bevespi Aerosphere (glycopyrronium/formoterol fumarate) is based on P-III PINNACLE 4 study results assessing […]Read More


AstraZeneca announces Results of AERISTO P-IIIb trial for Bevespi Aerosphere

Shots: The AERISTO study recruited 1,119 patients receiving either Bevespi Aerosphere (7.2/4.8µg) BID via pressurized metered-dose inhaler or umeclidinium/vilanterol (62.5/25µg) QD via dry powder inhaler Another P-III PINNACLE study enrolled ~5,000 patients and is performed to test safety and efficacy of Bevespi Aerosphere vs. umeclidinium/vilanterol  Bevespi Aerosphere (glycopyrronium/formoterol fumarate) is approved in the US and […]Read More