Prurigo Nodularis Medicine Nemluvio Approved by FDA

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Galderma announced today the FDA approval of Nemluvio (nemolizumab) for adults with prurigo nodularis, according to the details of a news release published this morning. Nemluvio is the first approved medication that specifically targets IL-31, the neuroimmune cytokine responsible for multiple disease mechanisms in prurigo nodularis.

Prurigo nodularis is a skin condition characterized by itchy, firm lumps mostly seen on the arms, legs, back and torso that turn into lesions when scratched. Severity can vary from a few lesions to several hundred. An estimated 181,000 in the United States are affected. The exact cause is unknown and there is no cure. Sufferers usually turn to a combination of topical steroid creams, cortisol injections or oral antihistamines. Prurigo nodularis can affect anyone, but it is most common in older adults.

Nemluvio comes in the form of a 30 mg pre-filled pen for subcutaneous injection. The first dose for all patients is 60 mg. For patients who weigh over 198 pounds, 60 mg is given every four weeks. Patients who weigh less than 198 pounds receive 30 mg every four weeks.

This approval is based on the results of a OLYMPIA clinical trials, which is the largest clinical trial program on this condition to date. During the trials, over 500 patients were given Nemluvio. Clinically meaningful improvements were seen by week 16 with 56% of participants reporting positive results. In fact, symptom progress was seen as early as week four when 40% of participants reported a decrease in severity.

“I’m delighted that Nemluvio has received U.S. FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life,” Shawn Kwarta, M.D., lead investigator of the Olympia program said in the news release. “By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”

The most common side effects reported were headaches and skin rashes such as eczema and atopic dermatitis. Patients should not receive live vaccines while taking Nemluvio.

"Healthcare providers may begin prescribing Nemluvio today by downloading the GPS for Nemluvio Enrollment Form at nemluvio.com," a Nemluvio representative said in an email to Managed Healthcare Executive. "Prescriptions are ready to be received by the Galderma Patient Services HUB and Specialty Pharmacies. Product inventory is being loaded into all distribution channels and will be available within the coming weeks."

Nemluvio is also being tested on patients with atopic dermatitis, according to a separate news release published last month. In recent trials, 16% of patients reported an improvement in itch after just one dose.