Merck, Johnson & Johnson Submit Biologics License Applications for Pediatric Respiratory Syncytial Virus, Ulcerative Colitis

Image Credit: Adobe Stock Images/Татевик Багдасарян

Merck and Johnson & Johnson (J&J) have respectively recently announced the submission of two separate Biologics License Applications (BLAs) to the FDA for pediatric treatments for respiratory syncytial virus (RSV) and ulcerative colitis.

Merck

Today, Merck announced the FDA's acceptance of its BLA for clesrovimab, an investigational long-acting monoclonal antibody designed to protect infants from RSV during their first RSV season. According to the company, the BLA is supported by results from the randomized, placebo-controlled Phase IIb/III CLEVER trial, which is evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants; and interim results from the Phase III SMART trial, which evaluated the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease.¹ The primary endpoint of the CLEVER trial was the reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥ 1 indicator of lower respiratory infection (LRI) or severity compared to placebo through day 150 post dose.²

“Despite recent advances in RSV prevention, unmet needs remain for additional effective interventions to help protect infants and continue to help address the burden RSV places on families and the healthcare system. This regulatory milestone, along with promising results from our pivotal studies demonstrating efficacy in the prevention of RSV disease, marks important progress toward our goal of having clesrovimab available in time for the 2025-26 RSV season,” said Paula Annunziato, SVP, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, in a press release. “We look forward to working alongside the FDA on the review of clesrovimab, which, if approved, would be the first and only single dose immunization for infants regardless of weight designed to protect them for the duration of their first RSV season.”

Results found a 60.4% reduction in the incidence of RSV-associated MALRI requiring ≥ 1 indicator of LRI or severity compared to placebo through day 150 post dose. Further, clesrovimab reduced RSV-associated hospitalizations and RSV-associated LRI hospitalizations by 84.2% compared to placebo. In the SMART trial, results found that clesrovimab had a comparable safety profile to palivizumab, and no drug-related serious adverse events were reported.²

The FDA has set a Prescription Drug User Fee Act date of June 10, 2025. Merck expects the treatment to be available in time for the 2025-26 RSV season.

Johnson & Johnson

Yesterday, J&J announced that it submitted a BLA seeking to expand the approved indication of Simponi (golimumab) for moderately to severely active ulcerative colitis in children aged two years and older. According to the company, the application is supported by the PURSUIT program, which evaluated the safety, efficacy, and pharmacokinetics of Simponi for this indication. Currently, the treatment is available for adults living with moderately to severely active ulcerative colitis.³

“This submission marks an important step in addressing the unique and pressing high unmet needs of children and adolescents living with ulcerative colitis, a challenging and lifelong inflammatory disease,” said Esi Lamousé-Smith, MD, PhD, VP, gastroenterology disease area lead, immunology, Johnson & Johnson Innovative Medicine, in a press release. “At Johnson & Johnson, we are committed to designing clinical programs that prioritize underrepresented populations, including pediatric patients living with immune-mediated diseases, to ensure access to safe and effective treatment options. We look forward to working with the Agency in their review of this Simponi pediatric application.”

References

1. Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season. Merck. December 17, 2024. Accessed December 17, 2024. https://www.merck.com/news/merck-announces-fda-acceptance-of-biologics-license-application-for-clesrovimab-an-investigational-long-acting-monoclonal-antibody-designed-to-protect-infants-from-rsv-disease-during-their-first-rsv/

2. Merck’s Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus (RSV) Preventative Monoclonal Antibody, Significantly Reduced Incidence of RSV Disease and Hospitalization in Healthy Preterm and Full-term Infants. Merck. October 17, 2024. Accessed December 17, 2024. https://www.merck.com/news/mercks-clesrovimab-mk-1654-an-investigational-respiratory-syncytial-virus-rsv-preventative-monoclonal-antibody-significantly-reduced-incidence-of-rsv-disease-and-hospitalization-in-heal/

3. Johnson & Johnson submits application seeking U.S. FDA approval of SIMPONI^® (golimumab) for the treatment of pediatric ulcerative colitis. J&J. December 16, 2024. Accessed December 17, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-seeking-u-s-fda-approval-of-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis