Weekly review: Dupilumab, lebrikizumab FDA approved, plus much more

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Get caught up with our journal! Review some of the top stories from the Contemporary Pediatrics website over the last week, and catch up on anything you may have missed.

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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, September 9, to Friday, September 13, 2024), and click on each link to read and watch anything you may have missed.

Dupilumab (Dupixent) becomes first FDA-approved drug for adolescent CRSwNP

The FDA has expanded the approval of the biologic dupilumab (Dupixent) to treat adolescents aged 12-17 years with chronic rhinosinusitis with nasal polyps (CRSwNP). Originally approved for adults in 2019, this new indication targets approximately 9,000 adolescents in the U.S. with poorly controlled CRSwNP, which can significantly affect breathing, sleep, and quality of life.

Standard treatments, such as systemic steroids and surgery, often fail to fully control symptoms or prevent recurrence. Dupilumab's approval was supported by the SINUS-24 and SINUS-52 trials, where it improved nasal congestion, polyp size, and the need for corticosteroids or surgery at 24 weeks. Additionally, adolescents reported an improved sense of smell.

Click here for full approval details.

FDA approves lebrikizumab for atopic dermatitis in patients 12 years and older

The FDA has approved lebrikizumab (EBGLYSS) for patients aged 12 and older with moderate to severe atopic dermatitis who meet specific weight and disease severity criteria. The treatment, developed by Eli Lilly and Company, is administered as a monthly injection and can be used with or without topical corticosteroids. It is designed for patients who have not adequately responded to topical prescription therapies.

Lebrikizumab's approval is based on data from the ADVocate 1 and 2 trials, as well as the ADhere trial.

Jonathan Silverberg, MD, PhD, MPH, emphasized the significance of lebrikizumab as a new first-line biologic option for those with moderate to severe atopic dermatitis, noting the challenges many patients face in achieving long-term disease control and managing severe itching. This approval follows a previous delay, with Eli Lilly resubmitting the drug application after receiving a Complete Response Letter (CRL) earlier in the process.

Click here for full approval details and study data.

ACIP recommends ≥1 updated COVID-19 vaccine booster for all children, adolescents

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends the 2024–2025 COVID-19 vaccine for everyone aged 6 months and older, using any FDA-authorized or approved vaccine. The updated vaccines from Moderna, Pfizer-BioNTech, and Novavax target newer strains like the Omicron JN.1 variant and are intended to provide protection into 2025.

Hospitalization rates for children during August 2024 were low, but the CDC emphasized vaccination, noting that half of hospitalized children during the previous year had no underlying conditions. FDA-approved vaccines for adults 12 and older and emergency-authorized vaccines for younger children are included in the recommendation.

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.

Click here for the full ACIP recommendations.

Metabolic profiles could help identify infants at higher risk for SIDS

New research published in JAMA Pediatrics highlights the unclear relationship between sudden infant death syndrome (SIDS) 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.

Using a case-control study within a larger retrospective cohort, researchers analyzed metabolic data from California-born infants between 2005 and 2011. 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.

For full details, click here.

LUM-201 phase 2 data for PGHD with Andrew Dauber, MD, MMSc

In this Contemporary Pediatrics interview, Andrew Dauber, MD, MSSc, Chief of Endocrinology at Children’s National Hospital in Washington, DC, broke down and highlighted phase 2 data for LUM-201 (Lumos Pharma), an oral secretagogue in development for moderate pediatric growth hormone deficiency (PGHD).

Click here for additional study details.

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