FDA Approves Dupilumab for Adolescent CRSwNP and Lebrikizumab for Atopic Dermatitis
Key Insights
Dupilumab (Dupixent) has gained FDA approval as the first drug for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps (search) (CRSwNP (search)), addressing a critical unmet need.
Lebrikizumab (EBGLYSS) received FDA approval for treating moderate to severe atopic dermatitis (search) in patients 12 and older, offering a new first-line biologic option.
ACIP recommends that all children and adolescents over 6 months receive at least one updated COVID-19 (search) vaccine booster for the 2024-2025 season, enhancing protection against newer strains.
The FDA has recently approved two significant treatments for adolescent patients: dupilumab for chronic rhinosinusitis with nasal polyps (search) (CRSwNP (search)) and lebrikizumab for atopic dermatitis (search). These approvals mark important advancements in addressing conditions that significantly impact the quality of life for young individuals.
Dupilumab Approved for Adolescent CRSwNP
Dupilumab (Dupixent) has been granted FDA approval to treat adolescents aged 12-17 years with chronic rhinosinusitis with nasal polyps (search) (CRSwNP (search)). This approval makes dupilumab the first FDA-approved drug for this age group with CRSwNP. Affecting approximately 9,000 adolescents in the U.S., CRSwNP can cause significant breathing difficulties, sleep disturbances, and reduced overall quality of life. The approval is based on data from the SINUS-24 and SINUS-52 trials, which demonstrated improvements in nasal congestion, polyp size, and sense of smell, as well as a reduced need for systemic corticosteroids or surgery at 24 weeks.
Traditional treatments for CRSwNP (search), such as systemic steroids and surgery, often fail to provide adequate long-term control of symptoms or prevent recurrence. Dupilumab, a biologic, offers a targeted approach to managing this condition in adolescents who have limited treatment options.
Lebrikizumab Approved for Atopic Dermatitis
Lebrikizumab (EBGLYSS), developed by Eli Lilly and Company, has been approved by the FDA for patients aged 12 and older with moderate to severe atopic dermatitis (search). Administered as a monthly injection, lebrikizumab can be used with or without topical corticosteroids. The approval is supported by data from the ADVocate 1 and 2 trials, as well as the ADhere trial.
According to Jonathan Silverberg, MD, PhD, MPH, lebrikizumab represents a significant new first-line biologic option for individuals with moderate to severe atopic dermatitis (search). Many patients struggle to achieve long-term disease control and manage severe itching with existing therapies. The approval follows a previous delay, with Eli Lilly resubmitting the drug application after receiving a Complete Response Letter (CRL) earlier in the process.
ACIP Recommends Updated COVID-19 Vaccine Boosters
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends the 2024–2025 COVID-19 (search) vaccine for everyone aged 6 months and older, using any FDA-authorized or approved vaccine. The updated vaccines from Moderna, Pfizer-BioNTech (search), and Novavax target newer strains like the Omicron JN.1 variant (search) and are intended to provide protection into 2025. The ACIP advises one dose for children aged 5–11 without severe immunocompromise, and adults over 12. Those choosing Novavax may need two doses. Immunocompromised children require a multidose series. These guidelines aim to protect against circulating COVID-19 strains.
Metabolic Profiles and SIDS Risk
New research published in JAMA Pediatrics highlights the unclear relationship between sudden infant death syndrome (search) (SIDS (search)) and metabolic biomarkers. Led by Scott P. Oltman, MS, from the University of California San Francisco, the study examined newborn metabolic markers and their connection to SIDS, the leading cause of sudden unexplained infant deaths in the U.S. The study identified 14 metabolites associated with SIDS, including 17-hydroxyprogesterone, methionine, and free carnitine. Their model revealed distinct metabolic patterns in infants who died from SIDS, suggesting potential for targeted counseling and novel therapeutic pathways.