New Crohn’s Indication Puts Janssen’s Stelara On Equal Ground With Anti-TNFs
J&J’s Janssen Biotech subsidiary won FDA approval for the IL-12/IL-23 inhibitor Stelara to treat Crohn’s disease, giving it a second-line position alongside anti-TNF therapies for patients in need of new options.
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The company reported positive Phase II results and will move its potential fourth-to-market IL-23 inhibitor into Phase III in Crohn's disease later this year. Mirikizumab – in Phase III for psoriasis and ulcerative colitis – may be the second IL-23 drug for an IBD indication.
Recent launches Tremfya and Erleada are viewed as catalysts for continuing growth, along with ambitious plans to add indications for Imbruvica, Darzalex and Stelara.
US sales were down 14%, but much of the hit was due to a 2016 price adjustment that was felt across the pharma portfolio, and execs insisted the impact of biosimilars is more moderate than expected.