Japanese regulators approved three AstraZeneca treatments — including the world’s first triple-combination therapy for chronic obstructive pulmonary disease (COPD).
Breztri Aerosphere (budesonide/glypocyrronium/formoteral fumarate), known in trials by the name PT010, is the first of its kind for COPD in the world. The approval comes after AstraZeneca handed up results from a Phase 3 trial that showed statistically significant improvements in the amount of air patients could forcefully exhale in one second.
The Japanese Ministry of Health, Labor and Welfare also greenlighted Lynparza (olaparib), AstraZeneca’s joint cancer treatment with Merck, as a maintenance treatment after first-line chemotherapy for advanced ovarian cancer patients.
In yet another first (for Japan), Japan’s regulators approved AstraZeneca’s Bevespir Aerosphere (glycopyrronium/formoterol fumarate), a bronchodilator also aimed at COPD patients.