Johnson & Johnson’s and subsidiary Janssen have both applied for regulatory approval for Tremfya to the EMA and FDA. Image credit: Shutterstock / Skorzewiak.

Johnson and Johnson’s Tremfya (guselkumab) was superior to its Stelara (ustekinumab) medication in all endoscopic endpoints in a Phase II/III Crohn’s disease (CD) trial.

Data from the Phase II/III Galaxi trial (NCT03466411) showed that Tremfya was superior in endoscopic response, endoscopic remission, clinical remission and endoscopic response, and deep remission.

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The Phase II/III trial pitted Tremfya against J&J’s Stelara in adult patients with moderately to severely active CD.

Both maintenance doses, 100mg every eight weeks and 200mg every four weeks, met the composite co-primary endpoints compared to placebo in each study. When pitted against Stelaraboth doses demonstrated statistically significant and clinically meaningful differences on all endoscopic endpoints at 48 weeks.

The safety profile observed in the Galaxi programme is consistent with previous trials in approved indications.

This month, Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals), submitted applications to the European Medicines Agency (EMA) to expand the marketing authorisation application for Tremfya for adult patients with moderately to severely active ulcerative colitis (UC) and moderately to severely active CD.

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Johnson & Johnson took the lead with the regulatory application for Tremfya for the treatment of adults with moderately to severely active UC in other countries or regions including the US.

On 21 May, Johnson & Johnson announced that Tremfya met the primary endpoints in a Phase III UC trial.

The Galaxi programme included one Phase II dose-ranging study (Galaxi 1) and two confirmatory Phase III studies (Galaxi 2 and 3).

CD landscape

Crohn’s disease is a type of inflammatory bowel disease characterised by chronic inflammation of the gastrointestinal (GI) tract.

Crohn’s disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. Approximately 30% of people with Crohn’s disease develop symptoms before the age of 20.

A GlobalData report estimates CD drug sales across the eight major markets (8MM: US, France, Germany, Italy, Spain, the UK, Japan, and Canada) will increase from $9.5bn to $15bn by 2032. This growth is predicted to be driven by the approval and launches of 15 pipeline, generic, and biosimilar therapies.

GlobalData is the parent company of the Clinical Trials Arena.