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

Japan's health agency has approved AstraZeneca Plc's 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.
Price Action: AZN shares are up 1.45% at $53.79 during the premarket session on the last check Tuesday.