Janssen Gets Positive European Opinion for Crohn’s Disease Drug
Janssen-Cilag International, a Johnson & Johnson company, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending marketing authorization in the European Union for Stelara (ustekinumab) for 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.
Following this positive opinion, a final decision from the European Commission is expected later this year. Janssen is also currently seeking approval for ustekinumab for treating adult patients with moderately to severely active Crohn’s disease in the US.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate-to-severe plaque psoriasis in 87 countries, psoriatic arthritis in 71 countries and paediatric psoriasis in 34 countries.
Source: Johnson & Johnson