Johnson & Johnson expands portfolio with Tremfya approval for ulcerative colitis

Johnson & Johnson (J&J) has received approval from the U.S. Food and Drug Administration (FDA) for a third indication of its successful immunological therapy Tremfya (guselkumab). The drug is now also approved for the treatment of adults with moderate to severe ulcerative colitis (UC), marking another milestone in the company's history. Tremfya was previously approved for indications of plaque psoriasis and active psoriatic arthritis (PsA) in various countries, including the United States and Europe. The latest approval is based on data from the Phase IIb/III-QUASAR study, which demonstrated that a significantly higher proportion of UC patients treated with Tremfya achieved clinical remission after 44 weeks compared to placebo. A corresponding approval by the European Medicines Agency (EMA) is also currently under review. Additionally, in June 2024, J&J submitted a marketing authorization application for Tremfya to expand its use to moderate to severely active Crohn's disease (CD). Similar regulatory review by the EMA is underway. With this strategic expansion into the field of inflammatory bowel diseases (IBD), J&J is optimally positioned to achieve the projected revenue of $5 billion through Tremfya. This is particularly important as the current blockbuster Stelara will lose its market exclusivity in the U.S. next year and will be subject to pricing pressure under the national drug price negotiation program, part of the Inflation Reduction Act of 2022, starting in 2026. In the first half of 2024, Tremfya generated $1.7 billion, representing a 29% increase compared to the previous year. Given the strong market performance and significant market share gains, J&J plans to further develop Tremfya as a central growth driver in the field of immunology and IBD therapies. In a highly competitive market, other major players like AbbVie and Eli Lilly are also competing. AbbVie's Skyrizi and Rinvoq, as well as Eli Lilly's Omvoh, are significant competitors, supporting their revenue growth through approvals in new indication fields. J&J's current market value shows a moderate increase of 5.1% since the beginning of the year, but it lags behind the 24.2% overall increase in the industry sector. The company currently holds a Zacks Rank #4 (Sell).