Johnson & Johnson (JNJ) said Thursday that the US Food and Drug Administration has approved its drug Tremfya for the treatment of adults with moderately to severely active Crohn's disease, a chronic inflammatory gastrointestinal tract condition.
The approval follows results from a 1,300-patient phase 3 trial showing Tremfya was superior to Stelara in all pooled endoscopic endpoints, the company said.
This approval follows FDA approval of the drug, also called guselkumab, for treating moderately to severely active ulcerative colitis, the company said.
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