Johnson & Johnson's Janssen Pharmaceutical unit said Monday that the FDA has approved its filing seeking to expand the label for Stelara (ustekinumab) to include adults with moderately-to-severely active ulcerative colitis. David Lee, head of immunology at Janssen R&D, commented "with today's milestone, Stelara has received its fifth FDA approval since 2009." EU regulators approved Stelara for the same indication last month.
The FDA decision was based on data from Phase III UNIFI trial which involved patients with moderately-to-severely active ulcerative colitis considered unsuitable for treatment with conventional or biologic therapies. The study included an initial induction phase, where patients received a single dose of Stelara by intravenous infusion, and was followed eight weeks later by a maintenance phase, during which patients received subcutaneous injections of the interleukin-12 and -23 antagonist every eight weeks for 44 weeks.
Results demonstrated that the drug both induced and maintained clinical remission in a significantly greater proportion of patients than placebo. Specifically, results from the induction portion showed that 19% of Stelara-treated patients achieved clinical remission within eight weeks. Johnson & Johnson said the therapy also provided rapid relief of symptoms, with 58% of patients experiencing a clinical response at week 8. In the maintenance portion, 45% of patients receiving Stelara were in remission at one year. Further, Johnson & Johnson said the drug helped patients achieve clinical remission without the use of corticosteroids, with 43% achieving clinical remission and not receiving steroids at one year.
UNIFI also assessed a novel histologic-endoscopic mucosal improvement endpoint. Results showed that 17% of patients on Stelara achieved improvement of the intestinal lining at week 8 in the induction phase, while 44% did so at one year in the maintenance phase. However, the company noted that the relationship of histologic-endoscopic mucosal improvement to long-term outcomes was not evaluated in the trial. After completion of the maintenance study, a long-term extension continues to follow eligible participants for an additional three years.
Stelara is already approved to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis and moderately-to-severely active Crohn's disease in adults. It is also cleared for moderate-to-severe plaque psoriasis in adolescents aged 12 years and older, with Johnson & Johnson recently applying to the FDA to have the label expanded to include children ages six to 11 years.
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