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AstraZeneca Receives Japanese Approval For Lung Disease Treatment

AstraZeneca Plc. (AZN.L,AZN) said that Japan approved Breztri Aerosphere, formerly PT010, as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease or COPD.

It is the first approval by the Japanese Ministry of Health, Labour and Welfare for a triple-combination therapy in a pressurised metered-dose inhaler, which uses the Aerosphere delivery technology.

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.

Breztri Aerosphere is under priority review in China, with a regulatory decision expected in the second half of 2019. The medicine is also under regulatory review in the US and EU with decisions anticipated in 2020.

In a separate press release, AstraZeneca and Merck & Co Inc. (MRK) said that Japan aproved Lynparza or olaparib as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated or BRCAm advanced ovarian cancer, as detected by an approved companion diagnostic test.

The Japanese approval follows European Commission marketing authorisation announced in June 2019. Interactions with regulatory authorities in the rest of the world are ongoing, AstraZeneca said.

Ovarian cancer is a leading cause of cancer deaths in women worldwide. Most women diagnosed with Stage IV ovarian cancer have a five-year survival rate of approximately 17%.

BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells.

When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.

Separately, AstraZeneca said that Japan has approved Bevespi Aerosphere  as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease.

Bevespi Aerosphere is already approved in the US, EU, Canada, Australia and other countries as a dual bronchodilator for the maintenance treatment of moderate to very severe COPD.

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