The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases.
Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions.
With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population.
A decision from the US FDA is anticipated in late 2022.
Stelara is the first and only biologic targeting both cytokines interleukin -12 and IL-23, both of which play an important role in inflammation associated with immune-mediated diseases like PsA.
Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has received approval for four additional indications: children (ages six and older) with moderate to severe plaque psoriasis, adults with active PsA, adults with moderately to severely active Crohn's disease and adults with moderately to severely active ulcerative colitis.
Juvenile arthritis occurs in an estimated 20 to 45 children per 100,000 children in the US, with approximately 5 % of those children having jPsA.
jPsA is characterized by both joint inflammation and psoriatic skin lesions that resemble adult PsA. PsA can be a challenging disease to treat especially in younger populations, reinforcing the need for additional treatment options.
Stelara (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients (18 years or older) with active PsA, used alone or in combination with methotrexate; adult patients (18 years and older) with moderately to severely active Crohn's disease; adult patients (18 years and older) with moderately to severely active ulcerative colitis.
BenevolentAI reports positive Phase Ia safety and pharmacokinetic data for BEN-8744
Thermo Fisher Scientific unveils CorEvitas registry for generalized pustular psoriasis
Nektar Therapeutics commences Phase 2b rezpegaldesleukin clinical trial for alopecia areata
Innovent Biologics doses first participant in first-in-human phase one clinical trial of IBI3002
Ananda Developments secures CBD Drug Supply Agreement for endometriosis clinical trial
Trellus Health secures agreement with major US health plan for IBD management
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP