Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, June 9, to Friday, June 13, 2025), and click on each link to read and watch anything you may have missed.
FDA approves clesrovimab to protect infants during first RSV season
On June 9, 2025, the FDA approved clesrovimab (Enflonsia; Merck), a long-acting monoclonal antibody for the prevention of respiratory syncytial virus (RSV) disease in infants during their first RSV season. The approval was based on data from the phase 2b/3 CLEVER trial and the phase 3 SMART trial, which demonstrated that a single intramuscular dose of clesrovimab significantly reduced the incidence of RSV-associated medically attended lower respiratory infections and hospitalizations in healthy preterm and full-term infants.
Click here for full approval details.
Octavio Ramilo, MD, reacts to the FDA approval of clesrovimab for RSV prevention
“I think this is very exciting news. RSV was discovered almost 60 years ago, and until the recent couple of years, we had nothing really effective that could achieve RSV prevention in the whole population," said Octavio Ramilo, MD, chair of the Department of Infectious Diseases at St. Jude Children’s Research Hospital.
With the addition of clesrovimab, alongside nirsevimab and Pfizer's maternal RSV vaccine, Ramilo said clinicians now have multiple tools to offer broader protection.
“Now we move to a totally different era,” he said. “We have 2 monoclonal antibodies, nirsevimab and now clesrovimab, as well as a maternal vaccine, that are all indicated to prevent RSV disease during the first season.”
Dupilumab improves atopic dermatitis severity in adolescents, adults with skin of color
On June 7, 2025, Regeneron Pharmaceuticals and Sanofi announced new phase 4 data from the DISCOVER trial showing that dupilumab (Dupixent) improved overall disease severity, itch, and post-inflammatory hyperpigmentation in patients with moderate-to-severe atopic dermatitis (AD) and skin of color. The findings, shared at the 2025 Revolutionizing Atopic Dermatitis (RAD) conference, mark the first large-scale clinical trial results for dupilumab in a population with darker skin tones.
Click here for findings and full results.
First infant enrolled in trial of roflumilast cream, 0.05% for atopic dermatitis in infants
On June 10, 2025, Arcutis Biotherapeutics announced the enrollment of the first infant in its phase 2 INTEGUMENT-INFANT trial evaluating roflumilast cream 0.05% for the treatment of mild-to-moderate atopic dermatitis (AD) in children aged 3 months to under 2 years. The open-label study will assess safety and tolerability over four weeks in approximately 35 infants, addressing a significant treatment gap for this vulnerable population. Roflumilast cream 0.05% is a topical phosphodiesterase-4 inhibitor, and the new infant trial builds upon Arcutis’ expanding clinical program for pediatric AD.
Click here for more details and other approved indications for roflumilast.
FDA expands glecaprevir/pibrentasvir indication for acute hepatitis C down to 3 years of age
On June 11, 2025, the FDA approved an expanded indication for AbbVie's glecaprevir/pibrentasvir (Mavyret), allowing its use in patients aged 3 years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. Mavyret is now the first and only 8-week, pangenotypic oral treatment available for this pediatric population, enabling earlier intervention at the time of diagnosis.
Click here for the full article.