Clinical trial waiver in China opens door to 2022 filing for ALK's dust mite allergy tablet
Danish allergy immunotherapy specialist ALK Abello (ALKB: DC) said today that it expects to submit a registration application in China for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet already in 2022, sending its shares up 3% by close of trading.
In preparation for this application, 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.
A registration trial waiver from the Chinese authorities now allows ALK to submit a Biologics Licence Application (BLA) in China without finalizing the local Phase III trial. Instead, 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.
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