European Medicines Agency committee grants accelerated review for XBiotech’s Xilonix — 4 takeaways

The Committee for Medicinal Products for Human Use of the European Medicines Agency granted accelerated review for Xilonix by XBiotech, a biopharmaceutical company and developer based in Austin, Texas, according to Street Insider.

Advertisement

Here are four takeaways:

1. Xilonix is XBiotech’s first-in-class monoclonal antibody treatment for advanced colorectal cancer.

2. A decision on Xilonix’s approval could come as early as third quarter 2016.

3. XBiotech recently received approval of its marketing authorization application for Xilonix based on results of a phase III study, which showed a 76 percent relative improvement in response rate in patients treated with the antibody as compared to placebo.

4. In the United States, Xilonix has received Fast Track designation by the FDA for the treatment of advanced colorectal cancer.

More articles on GI & endoscopy:
4 GI physicians in the news — April 1, 2016
Gastroenterologist pay by US region: 9 notes
FDA approves rare liver disease treatment: 4 things to know

Advertisement

Next Up in GI & Endoscopy

  • As colonoscopy demand rises, driven in part by more diagnostic referrals for patients under 55, GI leaders are also seeing…

  • Medical device company and surgical equipment manufacturer ConMed plans to exit its gastroenterology product lines.  ConMed’s gastroenterology segment is projected…

Advertisement

Comments are closed.