Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Shots:

  • The approval is based on P-III studies KX01-AK-003 and KX01-AK-004 that evaluated the efficacy and safety of Klisyri (tirbanibulin, ointment 1%, 10 mg/g) vs vehicle in 702 adult patients in the ratio of (1:1) with actinic keratosis of the face or scalp
  • Both the studies achieved their 1EPs defined as 100% clearance of the AK lesions @57 days within the treatment areas, complete clearance (44% vs 5% and 54% vs 13%) respectively
  • Klisyri is the first FDA approved product for Athenex and will be launched in partnership with Almirall in the US during Q1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Athenex

The post Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp first appeared on PharmaShots.