• (PLX AI) – ALK-Abello Clinical trial waiver in China opens door to 2022 registration filing for ALK’s dust mite allergy tablet.
  • • ALK-Abello can submit BLA in China without finalising the local Phase III trial
  • • ALK has completed a Phase I trial in China and had initiated a Phase III, local registration trial in adult allergic rhinitis. However, the Phase III trial has been paused since 2020 as a consequence of the COVID pandemic
  • • Now the waiver permits the relevant data in Chinese patients to be obtained as a follow-up activity, after the tablet’s potential approval and launch

Quelle: PLX AI