EU approval for Crohn's another boost for fast-growing Stelara

Janssen’s big-selling Stelara has been approved for second-line treatment of Crohn’s disease in the European Union.

The new use in the EU  means Stelara's label is now almost the same as in the US, where it has become well established in psoriasis, and psoriatic arthritis, and was approved in Crohn’s disease earlier this year.

Stelara is a blockbuster drug for the Johnson & Johnson unit, amassing sales of more than $800 million in Q3 alone, an increase of almost 36% compared with last year.

With the new Crohn’s disease use, it looks likely that the drug’s upward trajectory will continue.

The European Commission approved Stelara (ustekinumab) for 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 antagonist or have medical contraindications to such therapies.

Stelara is the first biologic therapy for Crohn's disease that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses.

The drug will have a 12-week dosing schedule, or eight weeks if patients lose response.

Approval is based on data from three phase 3 trials which included approximately 1,400 patients with moderately to severely active Crohn’s disease.

The studies showed that treatment with Stelara induced clinical response and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active Crohn’s disease after one year of therapy compared to placebo.

Janssen said the drug was generally well tolerated as an induction and maintenance therapy in all three studies, and the safety profile of Stelara in the Crohn’s disease clinical development programme remained consistent with five years of cumulative data acquired in patients with psoriasis and two years of safety data in patients with psoriatic arthritis

In the placebo-controlled IM-UNITI maintenance study adverse events were reported in similar proportions across Stelara and placebo treatment groups.  The majority of which were related to gastrointestinal disorders, such as abdominal pain and diarrhoea, and infections/infestations, of which, nasopharyngitis and upper respiratory infection were the most common.

Reported serious adverse events were similar in the Stelara groups compared to placebo and no deaths or major adverse cardiovascular events were reported.