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Janssen Submits Application for Stelara for Psoriatic Arthritis in Children
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.
Alyssa Johnsen, M.D., Ph.D.
“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.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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