AstraZeneca announces three new drug approvals in Japan

25 August 2022

UK pharma major AstraZeneca (LSE: AZN) this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence.

Lynparza (olaparib), which is partnered with US giant Merck & Co (NYSE: MRK), has been approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence.

This approval by the MHLW was based on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021. In the trial, Lynparza demonstrated a statistically-significant and clinically-meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001).

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