Phase III data demonstrates efficacy and safety of Klisyri

11 February 2021

Almirall (ALM: MC), the Spanish dermatology specialist, today announced that the New England Journal of Medicine (NEJM) has published the results from the pivotal Phase III trials of Klisyri (tirbanibulin) ointment for actinic keratosis; the two double-blind, vehicle-controlled, randomized, parallel-group, multicenter, trials (KX01-AK-003 and KX01-AK-004).

The company’s chief medical officer Dr Volker Koscielny commented: “We are delighted by the publication of the Phase III data for Klisyri in the NEJM, one of the most prestigious and rigorously peer-reviewed medical journals in the world. The clinical trial data presented not only demonstrates significant efficacy, but importantly a proven tolerability and safety profile. Added to the short 5-day application period, we believe that Klisyri provides an important addition to the therapeutic armamentarium of US dermatologists in treating actinic keratosis.”

Klisyri was approved by the US Food and Drug Administration in December last year to treat actinic keratosis of the face or scalp. The drug is also under regulatory review by the European Medicines Agency.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK