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J&J’s Tremfya Gains First IBD Indication, Setting The Stage For A Big Pharma Showdown

 
• By Jessica Merrill

The IL-23 inhibitor was approved by the US FDA for ulcerative colitis, joining AbbVie’s Skyrizi and Lilly’s Omvoh.

• Source: Shutterstock

Johnson & Johnson’s blockbuster psoriasis drug Tremfya (guselkumab) was granted US Food and Drug Administration approval on 11 September in what is expected to be a high growth indication: ulcerative colitis (UC). The approval for the treatment of moderately to severely active UC marks the first of two inflammatory bowel disease (IBD) indications the company expects to add for Tremfya, which is also pending at the agency for the treatment of Crohn’s disease. 

Key Takeaways

  • Tremfya’s first IBD indication is in ulcerative colitis, while an sBLA for Crohn’s disease is pending at FDA.

  • The IL-23 inhibitor will compete with other medicines of the same class, including AbbVie’s Skyrizi and Lilly’s Omvoh

UC and Crohn’s disease are two fast-growing therapeutic areas and J&J expects them to be growth drivers for the IL-23 inhibitor Tremfya as the company’s reliable immunology anchor, the IL-12/23 inhibitor Stelara (ustekinumab) faces biosimilar

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