www.fdanews.com/articles/178657-chmp-backs-janssens-stelara-for-crohns-indication
CHMP Backs Janssen’s Stelara for Crohn’s Indication
September 30, 2016
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to utilize Stelara to treat adults with active Crohn's disease who have had an ineffective or poor response to either conventional therapy or a tumor necrosis factor alpha (TNFα) antagonist or have medical appositions to such therapies.
Stelara is a human monoclonal antibody targeting interleukin-12 and -23 cytokines and has already received approved indication in Europe for the treatment of plaque psoriasis and active psoriatic arthritis.
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.