Japan’s health agency has approvedAstraZeneca Plc’sAZN 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.
