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An FDA decision is expected in late 2022.
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental biologics license application FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis.
The submission is based on data extrapolated from nine studies in adult trials in active psoriatic arthritis and adult and pediatric studies in moderate-to-severe plaque psoriasis. A decision from the FDA is anticipated in late 2022.
Juvenile psoriatic arthritis accounts for about 6% to 8% of all cases of juvenile arthritis cases. It is characterized by both joint inflammation and psoriatic skin lesions that resemble adult psoriatic arthritis.
“As children and their families manage the debilitating symptoms of juvenile psoriatic arthritis, it is critical that their physicians have a breadth of treatment options to consider,” Alyssa Johnsen, M.D., Ph.D., vice president, rheumatology disease area leader at Janssen Research & Development, said in a statement
Stelara targets cytokines interleukin-12 and IL-23, both of which play an important role in inflammation associated with diseases such as psoriatic arthritis.
Stelara is approved in the United States for the treatment of: adults and children 6 years and older with moderate-to-severe plaque psoriasis; adult patients with active psoriatic arthritis; adult patients with moderately to severely active Crohn’s disease or ulcerative colitis.