Galderma Laboratories, L.P. — NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use (2025-09-09)

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Silver Spring, MD 20993 Chase Edwards Director, Regulatory Affairs

2001 Ross Avenue, Suite 1600 Dallas, TX 75201

RE: BLA 761391 ® NEMLUVIO (nemolizumab-ilto) for injection, for subcutaneous use MA 57

Dear Chase Edwards:

The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer broadcast advertisement, “Scratch Resistance” (US-NAD-2400082 ® (v0.8)) (TV ad) for NEMLUVIO (nemolizumab-ilto) for injection, for subcutaneous use (Nemluvio) submitted by Galderma Laboratories, L.P. (Galderma) under cover of Form FDA 2253. FDA has determined that the TV ad is false or misleading. Thus, the TV ad misbrands Nemluvio and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The TV ad includes the following claims and presentations:

• VO: “…when moderate-to-severe eczema is uncontrolled despite treatment...” SUPER: “For adults and children 12+ years with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with topical prescriptions. NEMLUVIO can be used with certain prescription topicals.” • VO: “So when eczema is out-of-hand show it who’s boss with Nemluvio, Nemluvio”

The TV ad is misleading because it creates a misleading impression regarding the use of Nemluvio. Specifically, the claims and presentations above suggest that Nemluvio can be used alone for the treatment of moderate-to-severe atopic dermatitis, when this is not the case. While the TV ad presents information from the Patient Package Insert (PPI) regarding “What is NEMLUVIO?”, it fails to clearly convey that Nemluvio is indicated in combination with other topical treatments. According to the INDICATIONS AND USAGE section of the Prescribing Information (PI)(in pertinent part):

“NEMLUVIO is indicated…in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.”

In addition, the numerous benefit claims and data presentations regarding Nemluvio throughout the TV ad fail to reveal that the efficacy of Nemluvio is based on concomitant use with topical prescription treatments. Claims and presentations suggesting Nemluvio can be used, or has demonstrated efficacy, as a single agent in the treatment of moderate-to-severe atopic dermatitis are misleading.

The TV ad includes the following claims and presentations (emphasis original):

• VO: “Get itch relief fast, as soon as 48 hours.” Graphic: “ITCH RELIEF as soon as 48 HRS ” SUPER: “…In a follow-up analysis, results were observed as soon as 48 hours…” • VO: “Get over your itch fast…” GRAPHIC: “Get over itch fast…”

The TV ad is misleading because it creates a misleading impression regarding the efficacy of Nemluvio. Specifically, the claims and presentations above imply that treatment with Nemluvio provides itch relief as soon as 48 hours after treatment initiation, when this has not been demonstrated. According to the pivotal studies ARCADIA 1 and ARCADIA 2, Nemluvio showed an improvement in itch through a key secondary endpoint, a Peak Pruritus Numeric Rating Scale (PP-NRS) improvement greater than or equal to 4 points from baseline at Week 16 versus placebo (33% versus 15% and 36% versus 15%, respectively). However, daily PP - NRS response was a post-hoc, descriptive analysis for both ARCADIA 1 and ARCADIA 2. It was not a prespecified endpoint included in the Statistical Analysis Plan for these studies, was not adjusted for multiplicity, and no statistical procedures were in place for controlling inflation of the overall Type 1 error rate (false positive rate). As a result, alpha was not allocated for this analysis and it is not possible to determine the probability that the findings were attributable to treatment with Nemluvio rather than merely due to chance. The claims and presentations that draw benefit conclusions on this data are misleading.

The TV ad includes the following claims and presentations (emphasis original):

• VO: “…and get clear skin that lasts.” GRAPHIC: “CLEAR SKIN that lasts” SUPER: “…At 16 and 48 weeks, many on NEMLUVIO saw clear or almost clear skin…” • VO: “and get skin clearance that lasts.” GRAPHIC: “…with skin clearance that lasts”

The TV ad is misleading because it creates a misleading impression regarding the efficacy of Nemluvio. Specifically, the claims and presentations above suggest that patients with moderate-to-severe eczema (atopic dermatitis) will “get” complete clearing of their skin with Nemluvio, and many will maintain results “that last” through 48 weeks. According to the CLINICAL STUDIES section of the PI, the primary endpoint was the proportion of subjects who achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and at least a 2-point improvement from baseline at Week 16. The results of IGA success for Nemluvio at Week 16 were 36% and 38% versus 25% and 26% for placebo in ARCADIA 1 and ARCADIA 2, respectively. IGA response was also evaluated between 16 and 48 weeks in the combined trial maintenance period with 63% and 64% of Nemluvio patients from two

differing dosing regimens demonstrating IGA success versus 55% of placebo patients. However, contrary to the claims and presentations in the TV ad, experiencing clear skin and maintaining it is not a guarantee for any, let alone “many” patients at any timepoint. The proportion of Nemluvio patients with IGA success was well less than 50% at Week 16 and only represented a 12% difference from placebo across the two studies. Furthermore, the maintenance period data represents a subset of IGA responders at Week 48 out of the IGA responder subset from Week 16. Thus, the interpretability of the 48-week IGA data is only applicable to a limited population and does not support broad efficacy claims for “many” patients.

Conclusion and Requested Action

For the reasons described above, the TV Ad misbrands, Nemluvio and makes the distribution of the drug in violation of the FD&C Act.

This letter notifies you of our concerns and provides you with an opportunity to address them. FDA requests that Galderma take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Nemluvio that contain representations like those described above, and explaining your plan for the timely discontinuation of such communications, or for ceasing distribution of Nemluvio.

If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.

The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.

Please direct your response to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 . A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 57 in addition to the BLA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Untitled Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Additionally, the response submission should be coded as an Amendment to eCTD Sequence 6054 under BLA 761391. Questions related to the submission of your response letter should be emailed to CDER- OPDP-RPM@fda.hhs.gov .

Sincerely,

{See appended electronic signature page}

George Tidmarsh, M.D., Ph.D. Director Center for Drug Evaluation and Research

Signature Page 1 of 1 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------

CARTER M BEACH 09/09/2025 05:12:01 PM On behalf of George Tidmarsh, M.D., Ph.D