CIMZIA submitted for US FDA approval

UCB put out a press release announcing their submission for approval of a new anti-TNF drug. They note that:

If approved, CIMZIA would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.

To lightly paraphrase their results, data from PRECiSE 2 (the second of four studies) demonstrated that within six weeks of initiating CIMZIA, 64.1 percent of patients achieved a clinical response.

At the end of 26 weeks, significantly more patients, 62.8 percent on CIMZIA vs. 36.2 percent on placebo, maintained an overall clinical response. Additionally, at 26 weeks, significantly more of CIMZIA patients were in clinical remission compared to placebo patients. CIMZIA was generally well tolerated with an adverse event profile similar to other anti-TNF agents.

Reuters adds:

Cimzia will compete against Johnson & Johnson's Remicade in the Crohn's market and against Amgen's Enbrel and Abbott Laboratories' Humira -- as well as Remicade -- in arthritis.