The FDA has approved Anzupgo cream (delgocitinib) from Danish company LEO Pharma. It is the first treatment for chronic hand eczema in adults.

The US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream from LEO Pharma for the treatment of moderate to severe chronic hand eczema in adults. The Danish pharmaceutical company announced this in a press release.

The drug is approved for use in cases where corticosteroids are ineffective or contraindicated. It has proven its efficacy and safety in two Phase III studies, DELTA-1 and DELTA-2, involving 960 participants.

The condition of the skin on the hands was assessed using the IGA-CHE TS scale, which distinguishes five degrees of eczema severity: 0 — complete absence, 4 — extensive inflammation with cracks, blisters, and peeling. By week 16 of treatment with the cream, 20% of participants in DELTA-1 and 29% in DELTA-2 had either completely resolved (0) or minimally expressed (1) eczema symptoms. In the placebo group, 10% and 7% of patients achieved the same results, respectively.

In addition, they kept a daily diary in which they rated the intensity of pain and itching on a scale from 0 to 10. In both studies, nearly half (47–49%) of participants reported a reduction of more than four points thanks to the application of Anzupgo. In the placebo group, this figure was 23–28%.

The drug is a topical inhibitor of Janus kinases, proteins known as JAKs, which signal the need to initiate or intensify inflammatory processes in cells. It blocks the JAK-STAT signaling pathway, the activation of which leads to the development of eczema symptoms.

Chronic hand eczema is an inflammatory skin disease that affects about 10% of adults worldwide. It is accompanied by itching, pain, redness, peeling, as well as blisters and cracks on the hands and wrists. The condition has a negative impact on career growth and income levels, according to research data cited by LEO Pharma.

As noted, Anzupgo received approval from regulators in the European Union, Switzerland, the United Kingdom, and the United Arab Emirates last year.

 

Source: LEO Pharma