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Japan Approves AstraZeneca's Two Treatments For Asthma, Rare Form Of Cancer

Japan Approves AstraZeneca's Two Treatments For Asthma, Rare Form Of Cancer

日本批准阿斯利康治疗罕见癌症哮喘的两种疗法
Benzinga Real-time News ·  2022/09/27 08:58

  • Japan's health agency has approved $AstraZeneca (AZN.US)$AstraZeneca Plc's (NASDAQ:AZN) Koselugo (selumetinib) for pediatric patients with plexiform neurofibromas (PNs) in neurofibromatosis type 1 (NF1) with clinical symptoms and which cannot be entirely removed by surgery without the risk of substantial morbidity.

  • The approval is based on positive results from the SPRINT Stratum 1 Phase 2 trial that showed Koselugo reduced the size of inoperable tumors in children.

  • The SPRINT Stratum 1 Phase 2 trial showed Koselugo's objective response rate (ORR) of 66% (33 of 50 patients confirmed partial responses).

  • Japan also approved AstraZeneca's Tezspire (tezepelumab) for bronchial asthma in patients with the severe or refractory disease who cannot control asthma symptoms with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies.

  • Tezspire consistently and significantly reduced asthma exacerbations across the PATHWAY Phase 2 and NAVIGATOR Phase 3 trials.

  • 日本卫生厅已批准$阿斯利康 (AZN.US)$阿斯利康纳斯达克代码：AZN)Koselugo(Selumetinib)用于患有1型神经纤维瘤病(NF1)中丛状神经纤维瘤(PNS)的儿童患者，这些患者有临床症状，无法通过手术完全消除这些疾病，而不存在实质性发病的风险。

  • 这一批准是基于Sprint Stratform 1期2试验的积极结果，该试验显示Koselugo缩小了儿童无法手术的肿瘤的大小。

  • 斯普林特1期2期试验显示Koselugo的客观应答率(ORR)为66%(50名患者中有33名确认部分反应)。

  • 日本还批准阿斯利康的Tezspire(Tezepelumab)用于严重或难治性疾病患者的哮喘，这些患者无法通过中或大剂量吸入皮质类固醇和其他长期维持疗法控制哮喘症状。

  • Tezspire持续显著地减少了路径2期和导航器3期试验中的哮喘恶化。

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