Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

NEMLUVIO (BLA-761390)

(NEMOLIZUMAB-ILTO)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/26/2025 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Prurigo Nodularis

A total of 508 adult subjects with prurigo nodularis were treated with NEMLUVIO in two placebo-controlled trials and an open label long-term extension trial. Of these, 375 subjects were exposed for at least 1 year in the drug development program for prurigo nodularis.

The safety of NEMLUVIO in adult subjects with prurigo nodularis was evaluated in two randomized, double- blind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2). Subjects were treated for up to 24 weeks in OLYMPIA 1 and up to 16 weeks in OLYMPIA 2. In these 2 trials, 370 subjects were treated with subcutaneous injections of NEMLUVIO, and 186 subjects received placebo [see Clinical Studies (14.1)].

Subjects weighing less than 90 kg in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0, followed by a NEMLUVIO dose of 30 mg or placebo every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0 followed by a NEMLUVIO dose of 60 mg or placebo every 4 weeks.

…

Atopic Dermatitis

Adults and Pediatric Subjects 12 Years of Age and Older

A total of 1148 subjects, including 180 subjects 12 to 17 years of age, with moderate-to-severe atopic dermatitis were treated with NEMLUVIO for at least 1 year during the drug development program.

The safety of NEMLUVIO was evaluated in a pool of two randomized, double-blind, placebo-controlled, multicenter phase 3 trials (ARCADIA 1, ARCADIA 2). In these two trials, 1135 adult and pediatric subjects 12 years of age and older with moderate-to-severe AD were treated with subcutaneous injections of NEMLUVIO (initial dose of 60 mg, followed by 30 mg every 4 weeks), with concomitant topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) for up to 16 weeks (Initial Treatment Period) [see Clinical Studies (14.2)].

After the Initial Treatment Period, subjects who responded to NEMLUVIO were re-randomized to receive NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks, or placebo every 4 weeks for the Maintenance Treatment Period (Week 16 through Week 48) [see Clinical Studies (14.2)]. The safety population during the Maintenance Treatment Period had a mean age of 31 to 33 years (median age of 26 to 29 years) for the NEMLUVIO cohorts.

Week 0 to Week 16

In ARCADIA 1 and ARCADIA 2 trials through Week 16, the proportion of subjects who discontinued treatment because of adverse events was 2.3% in the NEMLUVIO every 4 weeks group and 2.2% in the placebo groups. Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% in the NEMLUVIO group, and for which the rate exceeds the rate in the placebo group during the first 16 weeks of treatment.

Table 2: Adverse Reactions Occurring in Greater than or equal to1% of Adult and Pediatric Subjects 12 Years of Age and Older with Atopic Dermatitis in the NEMLUVIO Group and Greater than in the Placebo Group in ARCADIA 1 and ARCADIA 2 Trials through Week 16

Please refer to label to view Table 2.

Assessment of the safety profile of NEMLUVIO in 505 subjects up through Week 48 in the ARCADIA 1 and ARCADIA 2 trials was generally consistent with the safety profile observed at Week 16.

Specific Adverse Reactions Hypersensitivity reactions

Type 1 hypersensitivity reactions (Ig-E mediated reactions) were reported in subjects treated with NEMLUVIO. This included occurrence of mild urticaria that did not lead to discontinuation of treatment.

Injection site reactions

The incidence of injection site reactions during the initial treatment period was reported for 1.2% of subjects treated with NEMLUVIO and 0.9% of subjects receiving placebo; during the maintenance period, the incidence was 0.6% with NEMLUVIO every 4 weeks, 0% with NEMLUVIO every 8 weeks, and 0% with placebo. None of these reactions led to discontinuation of treatment.

Herpes Zoster

During the initial treatment period, herpes zoster infections were reported in 5 subjects (0.4%) treated with NEMLUVIO (including 1 case of ophthalmic herpes zoster) and no subjects receiving placebo. Cases of herpes zoster were mild to moderate in severity and did not lead to discontinuation of treatment.

Pediatric Subjects 12 Years of Age and Older

The safety of NEMLUVIO was assessed in 176 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis enrolled in the ARCADIA 1 or ARCADIA 2 trials who received at least one dose of NEMLUVIO from Week 0 to Week 16 in the primary safety population. The safety profile of NEMLUVIO in these subjects through Week 16 was consistent with the safety profile observed in adults with atopic dermatitis.

The safety profile of NEMLUVIO in 98 subjects 12 to 17 years of age followed through Week 48 was consistent with the safety profile observed at Week 16.

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data). The clinical significance of this nonclinical finding is unknown.

The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, NEMLUVIO may be present in infants exposed in utero. The potential impact of infants being exposed in utero to NEMLUVIO should be considered.

Data

Animal Data

In an enhanced pre- and postnatal development study, subcutaneous doses up to 25 mg/kg of nemolizumab-ilto were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to parturition. No maternal or embryofetal toxicities were observed at doses up to 25 mg/kg (36 times the MRHD for PN and 50 times for AD, based on AUC comparison). Early postnatal death occurred in the offspring of one control monkey and 3 monkeys at 25 mg/kg (36 times the MRHD for PN and 50 times for AD, based on AUC comparison). The clinical significance of this nonclinical finding is unknown. Nemolizumab-ilto was administered subcutaneously to the offspring at doses up to 25 mg/kg (122 times the MRHD for PN and 168 times for AD, based on AUC comparison), once every 2 weeks for 6 months, starting from postnatal day 35. No adverse effects were noted in the remaining offspring.

8.4 Pediatric Use

Additions and/or revisions underlined:

Prurigo Nodularis

The safety and effectiveness of NEMLUVIO have not been established in pediatric patients.

Atopic Dermatitis

The safety and effectiveness of NEMLUVIO for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors have been established in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Use of NEMLUVIO for this indication is supported by evidence from two randomized, double-blind, placebo- controlled trials [See Adverse Reactions (6.1) and Clinical Studies (14.2)].

The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age.

8.5 Geriatric Use

Additions and/or revisions underlined:

Prurigo Nodularis

…

Atopic Dermatitis

Of the 1192 subjects with atopic dermatitis exposed to NEMLUVIO in the primary safety population, 72 (6.0%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 78 (4.5%) subjects 65 years of age or older. Clinical studies of NEMLUVIO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects [see Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Extensive additions and/or revisions, please refer to label for complete information.