FDA Approves Stelara for Crohn's Colitis Save

The anti-IL-12/IL-23 inhibitor, Stelara (ustekinumab) has been FDA approved for the treatment of psoriasis and psoriatic arthritis.  In the last week, the EMA's CHMP has recommended that the drug also be approved for use in Crohn's disease.

Today the FDA approved Stelara for use in adults with moderate to severely active Crohn's disease.

Late-stage trial data showed Stelara induced remissions in moderate-to-severe Crohn's disease patients who had previously failed to benefit from TNF inhibitors, a leading class of medicines for the inflammatory bowel disease.

Approval comes after the presentation of data at the Digestive Disease Week 2016 meeting in May 2016, wherein Janssen presented the results of three trials (UNITI-1, UNITI-2 and IM-UNITI) demonstrating its efficacy.

The UNITI-2 study assessed Stelara in patients who had failed conventional therapy and were naive to anti-TNF-alpha blockers. The UNITI-3 trial showed the efficacy of Stelara to induce remission in patients previously treated with TNF inhibitors. 

Crohn's colitis is thought to affect about 700,000 Americans. 

Ustekinumab is not approved for several conditions its under investigation for, including ankylosing spondylitis with positive results recently reported at EULAR 2016. (Citation source: http://buff.ly/2d3yIHd)