Advisors to the European Medicines Agency (EMA) are backing approval of Janssen's Stelara, bringing the drug closer to becoming the first interleukin (IL)-12/23 inhibitor licensed for Crohn's disease.
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Stelara (ustekinumab) to treat adults with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist or have medical contraindications to such therapies.
Janssen filed to drug in December last year on the back of data showing that, after six weeks' treatment, 52 percent of patients taking Stelara 130mg and 56 percent receiving the 6mg/kg dose achieved a clinical response, versus 29 percent in the placebo arm. After eight weeks (a secondary endpoint), the figures were 47 percent and 58 percent compared to 32%, respectively.
Both doses of Stelara also resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire, a health-related quality of life measure for patients with the condition, as well as markers of inflammation, including C-reactive protein, faecal lactoferrin and calprotectin.
Crohn's disease is a chronic inflammatory bowel disease that affects around 115,000 people in the UK and nearly 250,000 people in Europe. It's cause is not known and currently there is no cure, and new treatment options are urgently needed.
Stelara - a human monoclonal antibody targeting interleukin-12 and -23 cytokines, which are believed to play an important role in immune-mediated diseases such as Crohn's - is already approved in Europe for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.