LEO Pharma’s topical JAKi Anzupgo approved in KOR

First topical Pan-JAK inhibitor cream approved for moderate-to-severe chronic hand eczema

레오파마

Global dermatology specialized pharmaceutical company LEO Pharma (General Manager Jung-Bum Shin) announced on the 23rd that its chronic hand eczema treatment Anzupgo (delgocitinib) was officially approved by the Ministry of Food and Drug Safety on the 8th.

 

With the approval, adult patients in Korea suffering from moderate-to-severe chronic hand eczema (CHE) will now have access to a new treatment option that offers both efficacy and convenience.

 

Chronic hand eczema is a multifactorial inflammatory skin disease characterized primarily by itching and pain, defined as eczema persisting for more than 3 months or recurring at least twice within a year.

 

It is among the most common skin disorders affecting the hands, and a significant proportion of cases progress to chronic disease.

 

Globally, CHE affects about 1 in 10 adults and can severely impair quality of life by imposing functional, occupational, and psychological burdens.

 

Approximately 70% of patients with severe CHE struggle with daily activities, which directly affects their employment and income.

 

Anzupgo is the only non-steroidal topical cream formulation approved for adult patients with moderate-to-severe CHE who do not respond to or are unsuitable for topical corticosteroids.

 

The product contains no parabens or steroids and works by inhibiting the JAK-STAT signaling pathway involved in various inflammatory responses.

 

By blocking the activity of JAK1, 2, 3, and TYK2, the drug helps reduce skin inflammation and itching.

 

Multiple clinical trials have demonstrated broad efficacy across all subtypes of moderate-to-severe CHE.

 

Until now, treatment options for CHE have been limited, with strong topical corticosteroids used most frequently.

 

However, long-term use carries risks such as skin barrier damage, atrophy, and telangiectasias.

 

Due to this reason, in cases that show insufficient short-term improvement, guidelines have recommended combining topical calcineurin inhibitors or systemic corticosteroids.

 

Currently, the only approved oral therapy for severe chronic hand eczema is alitretinoin, used for patients unresponsive to at least 4 weeks of potent topical corticosteroids.

 

It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema with a high risk of recurrence.

 

However, its use has been constrained by risks including hepatotoxicity, thyroid dysfunction, dyslipidemia, and teratogenicity.

 

In the head-to-head DELTA FORCE trial that directly compared oral alitretinoin with Anzupgo, the Anzupgo group achieved a statistically superior improvement in HECSI scores at week 12 (-67.6).

 

It also demonstrated higher achievement rates in HECSI-90 and IGA-CHE TS (score 0/1).

 

Over the 24-week treatment period, Anzupgo showed a better safety profile and lower incidence of adverse events compared to alitretinoin, confirming both strong efficacy and good tolerability.

 

Jung-Bum Shin, General Manager of LEO Pharma Korea, stated: “Chronic hand eczema not only causes physical suffering but also serious social and emotional challenges.

 

We are pleased to be able to provide the much-needed treatment option, Anzupgo, in Korea with its approval.” Shin added, “We will do our best to ensure Anzupgo contributes to changing the treatment paradigm for chronic hand eczema and improving patients’ quality of life in Korea.” LEO Pharma has been continuing the global launch of Anzupgo, having secured official approval in Korea following approvals in Europe, the UK, Switzerland, the UAE, Canada, Australia, and the US.