FDA approves 1st-ever drug to treat disabling skin condition prurigo nodularis

The first and only treatment for the disabling skin condition prurigo nodularis has been approved by the Food and Drug Administration in a development a D.C. dermatologist calls “huge.”

Prurigo nodularis is a persistent condition that causes itching so intense that it disrupts sleep. It can prompt so much scratching that skin starts to bleed; it results in thick skin lesions called nodules, which can cover almost the entire body.

“The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases and can negatively affect mental health, activities of daily living and social interactions,” said Dr. Adam Friedman, professor and chair of dermatology at The George Washington University School of Medicine and Health Sciences.

Also for the first time, prurigo nodularis is being recognized as a condition rather than a symptom.



“The approval is a twofold success, both in defining prurigo nodularis as a unique disease, and vindicating those suffering (from it), who have been told that it’s secondary for many years. Most importantly, we have a medication that has been thoroughly studied that is effective at curtailing the underlying issues that cause this condition,” Friedman said.

“Finally having an FDA-approved medication for a condition that’s so disabling like prurigo nodularis is a huge win for both patients and practitioners,” he said.

Friedman was involved in the study that defined the disease.

“George Washington was one of several international sites that followed patients with prurigo nodularis to better understand the underpinnings of disease to really define it as a unique entity,” he said.

It’s estimated that 75,000 U.S. adults are living with prurigo nodularis, but Friedman said it is tough to say with accuracy because the disease wasn’t being correctly documented when previously considered to be a symptom.

Before the FDA approval of Dupixent (dupilumab), prurigo nodularis was managed with off-label therapies, none studied with the same rigor as an FDA-approved medication.

Overall, Friedman is encouraged by recent developments in the dermatology field.

“Never in the history of dermatology have we had so many FDA approvals in such a short amount of time, and what that tells me is that the FDA, the public, the industry, recognize how insanely disabling chronic skin conditions can be and how they can impact quality of life; and how there’s such a great need for targeted and specific therapies to address the variety of issues that our patients suffer with,” Friedman said.

Kristi King

Kristi King is a veteran reporter who has been working in the WTOP newsroom since 1990. She covers everything from breaking news to consumer concerns and the latest medical developments.

This content was republished with permission from CNN.

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