Dupilumab

Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo the first therapeutic in the U.S. specifically indicated for chronic hand eczema. Danish dermatology specialist Leo Pharma has scored an FDA approval that makes its JAK inhibitor cream Anzupgo (delgocitinib) the first therapeutic in the U.S. specifically indicated for chronic hand eczema (CHE).The endorsement covers adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not suitable. In September of last year, Anzpugo became the first topical treatment for the condition approved in Europe.Dermatologists hailed the approval as a long-awaited treatment option for a condition that is often overlooked despite it affecting 1 in 10 adults in the world. A recent study commissioned by Leo and conducted by Ipsos showed that more than half of nearly 200 dermatologists who were surveyed were frustrated by the lack of progress in the indication.They said current therapeutics for moderate to severe atopic dermatitis—which are often prescribed to treat CHE—don’t sufficiently translate as treatments for moderate to severe CHE.“Delgocitinib is a victory for CHE patients because it immediately elevates the standard of care for patients who have long awaited a better quality of life,” Christopher Bunick, M.D., Ph.D., associate professor of dermatology at the Yale School of Medicine and editor-in-chief of Dermatology Times, said in a statement touting the approval.Anzpugo also becomes the first topical pan-JAK inhibitor to reach the market in the U.S., Leo said. Pan-JAK inhibitors block multiple JAK enzymes, while selective JAK inhibitors target specific JAK enzymes. The only other topical JAK inhibitor on the market in the U.S. is Incyte’s Opzelura, which has been approved for eczema and vitiligo.By inhibiting the JAK-STAT pathway, Anzpugo blocks the activity of JAK1, JAK2, JAK3 and tyrosine kinase 2, suppressing inflammatory responses that trigger the onset of CHE and subsequent flares.CHE is a fluctuating disorder that causes itchy, painful, blistered, or swollen skin that can interfere with daily activities. It is considered chronic when it lasts for three months or recurs often. Leo acquired rights to delgocitinib in 2014 from Japan Tobacco, which retains its rights to the treatment in its home country, where the drug has been on the market for five years.The FDA approval of Anzupgo is a “significant milestone” for Leo in its strategy to expand its presence in the U.S., the company said. In preparation for the nod, Leo added that it has “upscaled” its operations, including a 50% increase in its sales force. The company has not revealed what it will charge in the U.S. for Anzupgo.“The approval of Anzupgo reinforces our commitment to investing in difficult-to-treat skin conditions to deliver new treatments to patients where the need is greatest,” Leo CEO Christophe Bourdon said in a July 23 release. The approval was backed by three successful phase 3 trials. Two identical studies reached their primary endpoint, with Anzupgo topping placebo cream. The treatment also excelled in an open-label extension study.Separately, in a head-to-head trial, Anzupgo topped GSK’s standard-of-care oral treatment Toctino (alitretinoin), which is approved in Europe but not in the U.S. After 12 weeks, Anzupgo demonstrated a “significantly greater least squares mean decrease” in hand eczema severity index scores compared to those for Toctino. On a 360-point scale, Anzupgo patients had a 67.6-point reduction versus a 51.5-point drop for those in the Toctino group.There are other companies pursuing approvals in CHE, including Regeneron and Sanofi, with their megablockbuster Dupixent. Clinical-stage biotechs Asana BioSciences and Afecta Pharmaceuticals also have compounds in development that have shown promise in the indication, according to a report from GlobalData.