Johnson & Johnson submits sBLAs for Tremfya for two pediatric indications
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Key takeaways:
- Tremfya (guselkumab) is an interleukin-23 inhibitor.
- The submissions are supported by clinical and pharmacokinetic data from multiple phase 3 studies.
Johnson & Johnson has submitted two supplemental biologics license applications to the FDA for Tremfya for the treatment of plaque psoriasis and juvenile psoriatic arthritis in children, the company announced in a press release.
The submissions outline that Tremfya (guselkumab, Johnson & Johnson), an interleukin-23 inhibitor, would treat moderate to severe plaque psoriasis in children aged at least 6 years and active juvenile psoriatic arthritis in children aged at least 5 years.
“There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function,” Liza O’Dowd, MD, vice president and immunodermatology disease area leader of Johnson & Johnson Innovative Medicine, said in the release. “This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases.”
The plaque psoriasis submission was supported by data from the phase 3, pediatric PROTOSTAR study as well as pharmacokinetic data from the phase 3, adult VOYAGE 1 and VOYAGE 2 studies.
The juvenile psoriatic arthritis submission was supported by pharmacokinetic analyses of two adult psoriatic arthritis studies, DISCOVER 1 and 2 in addition to safety data from the PROTOSTAR study.