- PMLiVE
Johnson & Johnson (J&J) has announced that its Tremfya (guselkumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease (CD).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be approved to treat moderately to severely active CD in adults who have had an inadequate response, lost response, or been intolerant to either conventional therapy or a biologic treatment.
CD is one of the two main forms of inflammatory bowel disease, which is estimated to affect nearly two million people across Europe. CD patients can experience a range of symptoms, including abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.
Offering both subcutaneous (SC) and intravenous (IV) induction options for CD, J&J’s Tremfya is designed to block IL-23, an important driver of immune-mediated diseases, while also binding to CD64, a receptor on cells that produce IL-23.
The drug is already approved in the EU to treat certain cases of plaque psoriasis and active psoriatic arthritis, and was recommended by the CHMP last month to treat moderately to severely active ulcerative colitis, the other main type of IBD.
The CHMP’s latest recommendation comes just one week after the US Food and Drug Administration approved Tremfya for CD and was supported by data from the late-stage GALAXI and GRAVITI programmes.
This included results from the GALAXI 2 and 3 studies, in which Tremfya demonstrated greater efficacy compared to J&J’s Stelara (ustekinumab) in endoscopic response and endoscopic remission at week 48.
Mark Graham, senior director, therapeutic area lead, immunology, J&J Innovative Medicine EMEA, said: “The results from the phase 3 studies demonstrate [Tremfya] has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for CD. [This] positive opinion by the CHMP marks an important step forward in offering a potentially new and differentiated treatment option for people living with this chronic and debilitating condition…”
The EC will now review the CHMP’s recommendations as it makes a final decision on Tremfya in both CD and UC.