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.

Teduglutide trial promising

Yahoo has a press release about a small study into an interesting experimental drug Teduglutide:

Overall, the study results showed a positive and consistent trend toward efficacy and a dose response favoring the highest dose group: 36.8% of patients receiving the highest dose of teduglutide reached clinical remission (Crohn's disease activity index (CDAI) score of less than 150 points) at week two versus 16.7% of the placebo group, while 55.6% of patients in the highest dose group reached clinical remission by week eight compared to 33.3% of the placebo group. Teduglutide was well tolerated with no serious adverse events related to the drug.

...

Teduglutide is a proprietary analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. A previous Phase 2 clinical study in patients with Short Bowel Syndrome showed that daily subcutaneous injections of teduglutide resulted in significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids.