Leo Pharma topical cream is now an FDA-approved chronic eczema medication
A form of chronic eczema that is currently developed specifically in hands, it has received the first FDA-approved drug, a topical cream from dermatologist Leo Pharma.
Wednesday's regulatory decision for Leo drug Delgocitinib covers treatment for moderate to severe manual eczema in adults whose disease has not yet responded to topical steroids. It also includes those who cannot take topical steroids. Denmark-based Leo will sell its new products under the Anzupgo brand.
Eczema, also known as atopic dermatitis, is an immune disease that manifests as red patches and scaly skin that sometimes itchy and sometimes even blisters. Manual eczema, also known as hand dermatitis, is usually caused by the irritation people encounter at work. Cleaners or chemicals used to clean, hairdressing and mechanical work can cause eczema. Chronic hand eczema is defined as manual eczema that lasts for three months or more, while hand eczema will recur twice or more within a year.
Anzupgo works by blocking the JAK-STAT pathway, a signaling pathway that works in the immune response. The nonsteroidal topical cream applied twice daily inhibits the inflammatory response by blocking four proteins in the pathway: JAK1, JAK2, JAK3 and TYK2.
LEO evaluated Anzupgo in two pivotal clinical trials that compared the study drug with an inert cream. The main goal is to show clear or almost clear skin at week 16. Both studies were consistent with statistically significant results. These studies also met the secondary goal of measuring pain and itching relief.
Oral JAK inhibitors come with black box warnings throughout the classroom, including cancer and cardiovascular problems. But these drugs are used as pills that circulate throughout the body. As a topical drug, Anzupgo is not expected to work beyond the skin. Adverse reactions reported in clinical studies include pain at the site of application, tingling and numbness, itching, and reactions that cause redness in the skin. Anzupgo's tags do not carry a black warning.
Anzupgo was originally developed by Japanese Tobacco (JT). In 2017, Leo authorized the right to develop the drug worldwide, except Japan, which reserves the rights. The product was approved by the European Commission last year. It has also been approved in Switzerland, the United Kingdom and the United Arab Emirates.
Privately held Leo is already present in Adbry's eczema, an antibody designed to block the signaling protein IL-13. Adbry was approved in 2022 and is administered as an injection every other week. Leo said Anzupgo has contributed to its strategy to expand its U.S. business.
“As the first and only FDA approved treatment [chronic hand eczema],Anzupgo represents an important advancement for many patients and further establishes our company’s commitment to bringing innovative treatments to the market to meet unmet needs of medical dermatology. ” North America executive vice president Robert Spurr said in a prepared statement.
Photo by Leo Pharma
