Therapy Areas: AIDS & HIV
ALK's regulatory filing for house dust mite allergy tablet accepted for review in China
3 February 2023 -

Danish pharmaceutical company ALK-Abelló A/S (ALK) (CPH:ALK-B) reported on Friday that its Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (AIT) tablet has been accepted for review by the National Medical Products Administration (NMPA) in China.

The BLA relates to the treatment of persistent moderate-to-severe HDM allergic rhinitis in patients aged 12-65.

ALK has already made the HDM tablet available in China's Boao Lecheng Medical Pilot Zone, where first prescriptions have been issued. The company said that it expects to gain valuable input from prescribers and patients in this pilot zone ahead of a nationwide launch of the tablet subject to approval by the authorities.

In early 2022, Chinese authorities issued a regulatory waiver allowing ALK to file for approval of the HDM tablet by utilising clinical data obtained outside China and without finalising a Phase III registration trial with Chinese subjects, which had to be paused in 2020 due to COVID-19. This waiver permits further data in Chinese patients to be obtained as a follow-up activity, after the HDM tablet's potential approval and launch.

ALK expects the Chinese regulatory review process to be completed in 2024.

The HDM tablet is marketed as ACARIZAX in Europe and a number of other international markets, as ODACTRA in the United States and as MITICURE in Japan.