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

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

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  • 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

Ref: AstraZeneca | Image: AstraZeneca

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