Home Health New Hand Eczema Treatment Anzupgo (Delgocitinib) Gets FDA Okay

New Hand Eczema Treatment Anzupgo (Delgocitinib) Gets FDA Okay

With the U.S. Food and Drug Administration (FDA) approval of Anzupgo (delgocitinib), adults dealing with persistent hand eczema may have a new treatment to make the intense dryness, itch, and pain more tolerable or even clear it entirely.

Anzupgo is the first topical medication aimed specifically at moderate to severe chronic hand eczema in adults who haven’t responded to topical steroids or can’t use them.

The cream is already approved by the European Commission and has been launched in several countries including the UK, Germany, and Switzerland.

“This approval is a meaningful advancement,” says Veena Vanchinathan, MD, a Bay Area dermatologist who was not involved in the drug’s development. “Having a treatment specifically studied and approved for this condition gives patients and dermatologists a new option, especially when other treatments haven’t provided enough relief,” says Dr. Vanchinathan.

What Is Chronic Hand Eczema?

Chronic hand eczema is a long-lasting inflammatory skin condition that affects about 1 in 7 people, says Elizabeth Houshmand, MD, a dermatologist in Dallas. Symptoms can include discoloration, dryness, intense itching, cracking, thickening, blistering, and even bleeding on the hands and wrists, she says.

“Hand eczema is unique because of the constant exposure our hands have to irritants, moisture, and friction,” says Dr. Houshmand, who wasn’t involved in the drug’s development. The condition is more prevalent in people who work with their hands and wash their hands more often — for example, hairdressers, bakers, and healthcare workers — because of frequent exposure to irritants and allergens, she says.

“The visibility and functionality of our hands make this condition not only painful but emotionally distressing. It deeply affects quality of life,” says Houshmand.

How Anzupgo Works

“This medication uses a completely new mechanism of action,” says Vanchinathan.

Unlike existing treatments that primarily focus on soothing the skin or reducing inflammation with steroids, Anzupgo targets a pathway that drives the inflammatory cycle, she explains.

When someone has chronic hand eczema, their immune system sends too many inflammatory signals to the skin. These signals are carried by molecules called cytokines. These cytokines travel through a pathway in the body known as the JAK-STAT pathway (short for Janus kinase–signal transducer and activator of transcription).

Anzupgo blocks this pathway by targeting four specific enzymes (JAK1, JAK2, JAK3, and TYK2) that help send those overactive signals. By interrupting these signals, the cream reduces inflammation, calms the immune response, and helps the skin heal.

In Clinical Trials, Anzupgo Led to Clearer Skin, Less Pain and Itch

FDA approval was based on two large-scale phase 3 trials, DELTA 1 and DELTA 2, which included nearly 1,000 adults with moderate to severe chronic hand eczema. Participants applied either Anzupgo or a nonmedicinal placebo cream twice a day for 16 weeks.

In DELTA 1, 20 percent of Anzupgo users achieved “clear” or “almost clear” skin, compared with 10 percent with the placebo cream. In DELTA 2, the success rate was 29 percent versus 7 percent for placebo.

The treatment also significantly reduced itch and pain, with almost half of Anzupgo users reporting a four-point or greater drop in both symptom scores by week 16.

This level of pain reduction could mean going from constant, disruptive discomfort to barely noticeable symptoms, which could allow people to work with their hands, sleep more soundly, and better perform daily tasks.

Improvement in chronic itching translates into better concentration, rest, and mental health. A four-point drop often means the itch has gone from unbearable to manageable or disappeared altogether.

Safety and Side Effects of Anzupgo

The cream is available in a 2 percent formulation. Each gram contains 20 milligrams (mg) of delgocitinib, and the FDA-approved usage is no more than 30 grams (g) over a two-week period or 60 g per month.

In studies, the safety profile of Anzupgo was similar to placebo. The most common side effects were:

  • Application-site reactions, including pain, itching, skin discoloration, or tingling
  • Mild skin infections like paronychia or cellulitis
  • Low white blood cells
Anzupgo is part of the class of drugs known as JAK inhibitors, which may lower the ability of the immune system to fight infections. Some people taking JAK inhibitors, in pill or topical form, have been hospitalized or died of infections. But unlike oral JAK medications, this cream does not have a black box warning about potentially serious side effects.

When Will Anzupgo Be Available and What Will It Cost?

Leo Pharma, Anzupgo’s manufacturer, is working to make the cream available in the United States by late September or early October 2025, says a spokesperson.

The company hasn’t disclosed the cost of the cream for U.S. consumers. The price patients can expect to pay at the pharmacy will depend on insurance coverage, copay tiers, and pharmacy benefit design, according to Leo Pharma.

People with commercial insurance may qualify for additional savings through the Anzupgo Copay Program, and the company plans to have a patient assistance program as well.

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