Tirbanibulin (1) – Klisyri®

• Clinical trials
  • The pharmaceutical manufacturer has submitted data from the two marketing authorisation trials, KX01-AK-003 and KX01-AK-004, in the dossier.
  • These studies are randomised, double-blind Phase III trials with an identical study design, in which tirbanibulin was compared with an inactive vehicle.

Adults with non-hyperkeratotic, non-hypertrophic actinic keratoses (Olsen Grade I) on the face or scalp

• An additional benefit is not proven.
• Overall, the pharmaceutical manufacturer has therefore not provided any data relevant to the benefit assessment.
• No direct comparative studies of tirbanibulin against the appropriate comparator therapy are available.
• As neither study included an active comparison with the appropriate comparator therapy, they are not suitable for assessing the additional benefit of tirbanibulin.
• Furthermore, a study duration of 8 weeks is considered too short for the indication in question.

Courtesy translation only, please refer to the German original.