Almirall has announced that Klisyri (tirbanibulin) has received expanded approval from the US Food and Drug Administration (FDA) to treat actinic keratosis (AK), a common precancerous condition.
The approval follows the company’s supplemental new drug application (sNDA) to expand the use of the microtubule inhibitor ointment on areas of the face or scalp to up to 100 cm2.
Characterised by rough, scaly patches of skin, AK is estimated to be responsible for 60% of all squamous cell carcinoma cases, the second most common form of skin cancer.
According to a recent survey by Almirall as part of AK Global Day 2024, AK has an estimated prevalence of 13.3% in Europe and 50% of the population experiences sunburn at least once a year.
First approved by the FDA in December 2020, the recent approval was supported by an additional phase 3 clinical safety study involving more than 100 adult AK patients in the US, which met all primary endpoints of the study.
Results for the safety and tolerability of Klisyri conducted on an area of 100 cm2 on the face or balding scalp of patients was consistent with the original pivotal trials conducted on an area of 25 cm2 for both local skin reactions and treatment-related adverse events, while also showing a percent reduction in AK lesion count in line with the one reported in the original studies.
Commenting on the approval, Karl Ziegelbauer, chief scientific officer, Almirall, said: “The FDA’s approval of the use of Klisyri for AK on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists.
“With patients experiencing AK over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.”
Klisyri has already received several approvals, including from the EU and UK in 2021, as a one-application daily treatment for five days for AK of the face and scalp in adults.
In March 2024, Almirall and Eloxx Pharmaceuticals entered into an exclusive agreement to license an oral therapy, ZKN-013, for rare dermatological diseases in a deal worth more than $470m.