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.
  • Price Action: AZN shares are up 0.18% at $67.76 during the premarket session on the last check Thursday.
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