J&J positions Tremfya as Stelara successor with FDA nod for ulcerative colitis
J&J positions Tremfya as Stelara successor with FDA nod for ulcerative colitis
The FDA on Wednesday approved Johnson & Johnson’s therapeutic antibody Tremfya (guselkumab) for the treatment of adult patients with moderate to severe active ulcerative colitis.
According to the pharma, Tremfya is now the first and only fully-human, dual-acting monoclonal antibody for ulcerative colitis (UC). Tremfya not only blocks IL-23 to dampen the inflammatory response but also targets the CD64 receptor on cells that secrete IL-23, such as activated macrophages and monocytes.
Christopher Gasink, J&J’s vice president for medical affairs, gastroenterology and autoantibody, in a statement said that the approval gives UC patients a new treatment option that provides “meaningful improvements in symptoms” as well as the “promise of remission.” J&J is also seeking approval for Tremfya in Crohn’s disease.
Tremfya is already approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis.
Backing Wednesday’s approval are findings from the Phase IIb/III QUASAR study, a randomized, double-blinded and parallel-group study that tested 200-mg and 100-mg doses of Tremfya in patients who had previously shown suboptimal response—or were otherwise intolerant to—conventional therapies, including biologics and JAK inhibitors.
Results showed that 50% of patients given 200 mg of Tremfya every four weeks achieved clinical remission at 44 weeks, compared with only 19% on placebo. Those who received the lower 100-mg dose every eight weeks had a clinical remission rate of 45%. The treatment effects for both dose groups were statistically superior to placebo, according to J&J.
