AstraZeneca gains two Japanese product approvals for COPD, including first global clearance for triple-combination therapy Breztri Aerosphere

AstraZeneca announced Wednesday that Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) gained approval in Japan to relieve symptoms of chronic obstructive pulmonary disease (COPD). The company noted that this is the first global regulatory clearance for the product, formerly known as PT010, while it is the first approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI).

Also on Wednesday, AstraZeneca said that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) garnered approval in Japan to relieve symptoms in patients with COPD. The company indicated that this is the first approval by the MHLW for a maintenance fixed-dose, long-acting dual bronchodilator in a pMDI.

AstraZeneca noted that approval of Breztri Aerosphere was based on data from the Phase III KRONOS trial in which the therapy demonstrated a significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for Japan, compared with the dual comparators Bevespi Aerosphere and PT009 (budesonide/formoterol fumarate). In the study, Breztri Aerosphere met six of seven primary endpoints versus dual comparators, whilst also showing a significant 52% reduction in the rate of moderate or severe COPD exacerbations compared with Bevespi Aerosphere.

Breztri Aerosphere combines the inhaled corticosteroid budesonide, the long-acting muscarinic agonist glycopyrronium and the long-acting beta2-agonist formoterol fumarate. AstraZeneca indicated that the Chinese National Medical Products Administration has granted priority review to Breztri Aerosphere, with a regulatory decision expected in the second half, while the medicine is also under review in the US and EU, with decisions due in 2020.

Meanwhile, AstraZeneca said that approval of Bevespi Aerosphere was based on data from the Phase III PINNACLE 4 trial, as well as the broader PINNACLE clinical programme in more than 5000 patients. The medicines is currently approved in a number of other markets, including the US, EU, Canada and Australia, as a dual bronchodilator for the maintenance treatment of moderate-to-very severe COPD.

Separately on Wednesday, AstraZeneca and Merck & Co. announced that the MHLW approved the PARP inhibitor Lynparza (olaparib) as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated advanced ovarian cancer.

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