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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療罕見癌症哮喘的兩種療法
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.

  • 日本衞生廳已批准$阿斯利康 (AZN.US)$阿斯利康納斯達克代碼：AZN)Koselugo(Selumetinib)用於患有1型神經纖維瘤病(NF1)中叢狀神經纖維瘤(PNS)的兒童患者，這些患者有臨牀症狀，無法通過手術完全消除這些疾病，而不存在實質性發病的風險。

  • 這一批准是基於Sprint Stratform 1期2試驗的積極結果，該試驗顯示Koselugo縮小了兒童無法手術的腫瘤的大小。

  • 斯普林特1期2期試驗顯示Koselugo的客觀應答率(ORR)為66%(50名患者中有33名確認部分反應)。

  • 日本還批准阿斯利康的Tezspire(Tezepelumab)用於嚴重或難治性疾病患者的哮喘，這些患者無法通過中或大劑量吸入皮質類固醇和其他長期維持療法控制哮喘症狀。

  • Tezspire持續顯著地減少了路徑2期和導航器3期試驗中的哮喘惡化。

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