AstraZeneca's COPD Triple Therapy Breztri Aerosphere Receives First Global Approval in Japan

Today, AstraZeneca announced that its triple therapy Breztri Aerosphere (formerly known as PT010) has been approved for marketing by the Japanese Ministry of Health, Labour and Welfare (MHLW) to alleviate symptoms in patients with chronic obstructive pulmonary disease (COPD). Breztri Aerosphere is a triple therapy comprising three active ingredients—budesonide, glycopyrronium, and formoterol fumarate—administered via the Aerosphere delivery technology. This marks the first global approval for this triple therapy.

COPD is a progressive disease that causes airflow obstruction in the lungs, leading to disabling dyspnea. It affects the lives of 384 million people worldwide and is projected to become the third leading cause of death globally by 2020. The primary goals of COPD treatment are to improve lung function, alleviate disease symptoms, and prevent disease exacerbation.

Breztri Aerosphere, also known as PT010, is a fixed-dose combination triple therapy consisting of budesonide (an inhaled corticosteroid), glycopyrronium bromide (a long-acting muscarinic antagonist), and formoterol fumarate (a long-acting β2-adrenergic agonist). It utilizes Aerosphere delivery technology and is available in a single inhaler.

This approval is based on the positive results of Breztri Aerosphere in the Phase 3 clinical trial named KRONOS. In this randomized, double-blind, Phase 3 trial involving 1,900 patients with moderate-to-severe COPD, Breztri Aerosphere significantly improved lung function compared to the dual therapy Bevespi Aerosphere or PT009. The results of this trial have been published in The Lancet Respiratory Medicine.

Dr. Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said, “Breztri Aerosphere offers a new triple therapy for patients with COPD. Its initial approval marks an important step toward providing new treatment options for COPD patients worldwide.”

References:

[1] AstraZeneca’s COPD triplet Breztri, rival to GSK’s Trelegy, nabs first nod from Japan. Retrieved June 19, 2019, from https://www.fiercepharma.com/pharma/astrazeneca-s-copd-triplet-breztri-rival-to-gsk-s-trelegy-nabs-first-nod-from-japan

Original Title: Express | World's First, AstraZeneca's Triple Therapy for COPD Approved for Launch in Japan

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