19th Jun 2019 08:30
(Alliance News) - AstraZeneca PLC on Wednesday announced drug approvals in Japan, including Lynparza for advanced ovarian cancer and Breztri Aerosphere for chronic obstructive pulmonary disease.
Breztri Aerosphere has been approved in Japan as a triple-combination therapy, making it the first global approval and only triple-combination therapy in a pressurised metered-dose inhaler device in that country.
Mene Pangalos, executive vice president of BioPharmaceuticals Research & Development at Astra, said: "Chronic obstructive pulmonary disease affects more than five million people in Japan, and Breztri Aerosphere offers these patients a new, powerful triple-combination therapy in a pressurised metered-dose inhaler. This first approval of Breztri Aerosphere is a significant step towards providing a new treatment choice to people living with chronic obstructive pulmonary disease globally."
In addition, Bevespi Aerosphere has been approved by the Japanese Ministry of Health, Labour
& Welfare for patients with COPD as a fixed-dose long-acting product to relieve symptoms.
Pangalos also commented on this approval, saying: "As the first medicine in its class to be approved in a pressurised metered-dose inhaler in Japan, Bevespi Aerosphere offers an important new treatment option and choice of inhaler device for patients with moderate to very severe chronic obstructive pulmonary disease."
Lynparza has also been approved in Japan for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer. This follows Tuesday's announcement that Lynparza has been approved in the EU for the same disease, with both approvals based on the success of AstraZeneca's phase 3 Solo-1 trial.
Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business Unit said: "This approval in Japan is a critical advance for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy are long-term remission or a cure, yet currently 70% of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in Solo-1 represents a major step forward in our ambition to transform patient outcomes."
Lynparza is part of a strategic oncology collaboration between Astra and US pharma company Merck & Co Inc and is being jointly developed by the two companies
Shares in AstraZeneca were down 0.6% at 6,373.00 pence on Wednesday morning.
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