dm+d

40121311000001104

New Medicines

Klisyri Non-hyperkeratotic, non-hypertrophic actinic keratosis in adults (max area up to 25cm2)

Information

Klisyri
New molecular entity
Almirall
Almirall

Development and Regulatory status

Launched
Launched
Launched
September 2021
Sep 21Launched in Germany. Has been available in the US since Feb 21 [13].
Sep 21Klisyri 10mg/g ointment in single-use sachets available in the UK. Price for 5 x 250g sachets = £59.00[14].
Aug 21Approved by MHRA for the treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults [13].
Jul 21Approved in EU; Almirall have already submitted a MAA to MHRA via the European Commission Decision Reliance Procedure [12].
May 21Recommended for EU approval by CHMP – the full indication is ‘Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. Klisyri will be available as 10 mg/g ointment [11].
Dec 20Approved in US for treatment of AK on the face and scalp [10]
Mar 20The FDA has the New DrugApplication for tirbanibulin ointment for the treatment of actinic keratosis (AK) for review, with target action date of Dec 30 2020 [7].
Mar 20Filed in EU via centralised procedure [8].
Dec 19Almirall expects the filing for Tirbanibulin in early 2020; they estimated US and EU launches in 2021 [6].
Nov 18Analysts predict US launch 2020 & ex US launch 2022 [4].

Category

A small molecule, non-ATP competitive Src kinase inhibitor
AK occurs most often in individuals with fair skin, blonde hair and blue eyes at a rate according to cumulative UV exposure. In the UK, prevalence has been reported to be around 19-24% of the population over the age of 60 years [1].
Non-hyperkeratotic, non-hypertrophic actinic keratosis in adults (max area up to 25cm2)
Topical

Trial or other data

Mar 19Two PIII studies, KX01-AK-003 and KX01-AK-004 compared KX-01 ointment 1% with vehicle only achieved their primary endpoint of 100% clearance of the AK lesions at Day 57 within the face or scalp treatment areas in 44% of patients (vs vehicle 5%) and 54% (vs vehicle 13%) respectively [5].
Jul 18Results from the two PIII trials AK-004 and AK-003 achieve the primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas [3].
Sep 17PIII AK-004 trial to evaluate the efficacy and safety of KX-01 ointment 1% in adults with actinic keratosis on the face or scalp starts (NCT03285490). The primary endpoint will be complete response rate i.e. the proportion of subjects achieving complete clearance of all actinic keratosis in the selected area in the study drug group versus the placebo group, assessed at 57 days. 300 patients will be recruited in the US [2].
Sep 17Pivotal PIII AK003 trial to evaluate the safety and efficacy of KX-01 ointment 1% in adults with actinic keratosis on the face or scalp starts (NCT03285477). The primary endpoint will be the percentage of patients with 100% clearance in the treatment area. 300 patients will be recruited in the US [2].

Evidence based evaluations

SMC

Klisyri Actinic keratosis in adults (max area up to 100cm2)

Information

Klisyri
Licence extension / variation
Almirall
Almirall

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

A small molecule, non-ATP competitive Src kinase inhibitor
AK occurs most often in individuals with fair skin, blonde hair and blue eyes at a rate according to cumulative UV exposure. In the UK, prevalence has been reported to be around 19-24% of the population over the age of 60 years [1].
Actinic keratosis in adults (max area up to 100cm2)
Topical