Back-To-Back Three Japanese Approvals For AstraZeneca's Rare Disease Treatments

The Japan regulatory authority has approved AstraZeneca Plc AZN and Merck Co Inc's MRK Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence.
This approval was based on results from the OlympiA Phase III trial. In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.
Japan approved AstraZeneca's other cancer drug, Tagrisso (osimertinib), for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery.
The approval was based on positive global ADAURA Phase 3 trial results.
Ultomiris (ravulizumab) has been approved in Japan for adult patients with generalized myasthenia gravis (gMG).
The approval covers anti-acetylcholine receptor (AChR) antibody-positive patients whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmapheresis.
The approval was based on positive results from the CHAMPION-MG Phase 3 trial, which showed Ultomiris was superior to placebo on the total disease score at Week 26.
Additionally, in prolonged follow-up results from the open-label extension, the clinical benefit of Ultomiris was observed over 60 weeks.
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