Therapy Areas: Devices
AstraZeneca granted three regulatory approvals in Japan
25 August 2022 -

Pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Thursday the receipt of approvals from the Japanese Ministry of Health, Labour, and Welfare relating to Lynparza, Tagrisso and Ultomiris.

Based on results from the OlympiA Phase III trial, the regulator approved Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence.

The first and only approved medicine targeting BRCA mutations in early breast cancer in Japan, Lynparza is being jointly developed and commercialised by AstraZeneca and Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada.

The Ministry also approved Tagrisso (osimertinib) for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery. This approval was based on results from the global ADAURA Phase III trial.

Tagrisso is the only EGFR-targeted medicine approved in Japan for the treatment of early-stage lung cancer after surgery.

In the third decision by the Ministry of Health, Labour, and Welfare, Ultomiris (ravulizumab) was approved for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis. Japan's Pharmaceuticals and Medical Devices Agency also indicated that Ultomiris can be considered for patients who cannot receive high-dose IVIg or plasmaphaeresis due to complications, adverse reactions or other limiting factors.

This approval of the first and only long-acting C5 complement inhibitor in Japan was based on results from the CHAMPION-MG Phase III trial.



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