Johnson and Johnson Submits FDA Request for Pediatric Tremfya Approval

Johnson & Johnson announced has submitted two supplemental biologics license applications (sBLAs) to the FDA for Tremfya (guselkumab) to be used in children aged 6 and older with moderate-to-severe plaque psoriasis (PsO) and children aged 5 and older with active juvenile psoriatic arthritis (jPsA).

Tremfya is a fully human monoclonal antibody that works by binding to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, which is an important factor in autoimmune diseases such as plaque psoriasis and jPsA, the news release explains.

The sBLA submission for plaque psoriasis indication is based on the combined data of the ongoing phase 3 PROTOSTAR study examining the effects of Tremfya on pediatric patients and previous data from phase 3 VOYAGE 1 and 2 studies of adults with moderate-to-severe plaque psoriasis, in which 73.3% and 70.0% of patients saw improvement of psoriasis symptoms.

The sBLA submission for the juvenile psoriatic arthritis indication is based on the ongoing adult studies DISCOVER 1 and 2 and Tremfya safety data from the PROTOSTAR study, in which only 3% of the 731 total patients had serious adverse effects.

The most recent Tremfya indication was approved in September 2024 to treat adults with moderate to severe ulcerative colitis.

In addition, Tremfya is also approved to treat adults with psoriatic arthritis and adults with moderate to severe plaque psoriasis. It is available in a 100mg/mL prefilled syringe, 200 mg/2 mL prefilled syringe and a 200 mg/20 mL single dose vial for intravenous infusion.

Financial support is available for Tremfya patients through their free Tremfya withMe program and some patients are able to get their prescription for $0. Patients who have insurance companies with a maximizer program are not eligible, according to the Tremfya website. As of Sept. 2024, the list price of Tremfya is $13,872.80 per dose.

Plaque psoriasis is an autoimmune disease that causes itchy and sometimes painful plaques to form on the skin. About one third of cases are diagnosed in childhood and about 20,000 children are diagnosed every year, the news release says. The scaly appearance of this skin disease can have negative effects on children’s self-esteem.

Juvenile psoriatic arthritis is a form of juvenile idiopathic arthritis, which is the most common form of childhood arthritis, affecting about 300,000 children in the United States, according to the Pediatric Orthopedic Society of North America. Juvenile psoriatic arthritis affects about 5% of the idiopathic arthritis population and causes both arthritis and psoriasis symptoms in patients, with psoriasis symptoms often appearing first.

"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, M.D., vice president and Immunodermatology Disease Area Leader at Johnson & Johnson, said in the news release.