AstraZeneca’s Breztri Aerosphere (PT010) and Bevespi Aerosphere Receive MHLW’s Approval for Chronic Obstructive Pulmonary Disease in Japan

AstraZeneca’s Breztri Aerosphere (PT010) and Bevespi Aerosphere Receive MHLW’s Approval for Chronic Obstructive Pulmonary Disease

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 Bevespi Aerosphere in 1,756 patients with moderate to severe COPD and is an approved therapy in the multiple countries including the US & EU
  • Breztri Aerosphere & Bevespi Aerosphere are triple & dual bronchodilator combination therapies, available as a pressurized metered-dose inhaler (pMDI) utilizing Aerosphere delivery technology respectively. PT009 is expecting its NMPA’s approval in H2’19 with anticipated EU & the US regulatory approval in 2020

Click here, Click here to read full press release/ article | Ref: AstraZeneca | Image: Chicago Tribune