US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the US Food and Drug Administration (FDA) to market its Tremfya (guselkumab) as a treatment for moderately to severely active Crohn’s disease (CD). This IL-23 inhibitor now offers both subcutaneous (SC) and intravenous (IV) induction options for the condition.
Previous Approvals and Market Expansion
The latest FDA endorsement follows previous approvals for the drug’s use in moderate to severe plaque psoriasis, active psoriatic arthritis, and active ulcerative colitis (UC), further expanding Tremfya’s market presence.
Tremfya’s Mechanism and Clinical Efficacy
Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64. Phase III trials demonstrated its robust efficacy, with both SC and IV formulations achieving clinical and endoscopic endpoints, solidifying its position as a versatile treatment option for inflammatory conditions.-Fineline Info & Tech
Leave a Reply