05:07 AM EDT, 09/12/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Wednesday that the US Food and Drug Administration has approved Tremfya for the treatment of adults with moderately to severely active ulcerative colitis.

The company said the approval is supported by data from the ongoing phase 2b/3 study evaluating Tremfya in adult patients with moderately to severely active ulcerative colitis. According to Johnson & Johnson ( JNJ ), data showed that 50% of the patients who receive a 200-milligram dose and 45% of patients under the 100-milligram dose achieved the primary endpoint of clinical remission at week 44.

Johnson & Johnson ( JNJ ) said the approval marks the third indication approved for Tremfya, in addition to plaque psoriasis and active psoriatic arthritis. The company said it has also submitted a supplemental biologics license application for Tremfya's approval for the treatment of Crohn's disease.

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