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

Benzinga Real-time News ·  Sep 27, 2022 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.

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