logo
Share SHARE
FONT-SIZE Plus   Neg

Novartis: Omalizumab Met All Goals In Phase III Safety Registration Study In CSU

Swiss drugmaker Novartis AG (NVS: Quote) Wednesday announced late-breaking results showing omalizumab met all primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria or CSU, a chronic and debilitating form of hives with limited approved treatment options.

GLACIAL is the second of three pivotal Phase III studies that examine the efficacy and safety of omalizumab in CSU.

The study results supported the efficacy, safety and tolerability of omalizumab in patients with refractory CSU, a chronic and debilitating skin disease with intractable itch and hives.

Up to 40 percent of CSU patients fail on antihistamines, even those taking up to four times the approved dose. Antihistamines, at the approved dose, are currently the only licensed treatment for CSU.

Omalizumab is not currently approved or indicated for CSU. Regulatory submissions for omalizumab in CSU are on track for later this year, Novartis noted. It is being jointly developed by Novartis and Genentech, Inc.

The data was presented for the first time at the European Academy of Allergy and Clinical Immunology-World Allergy Organization World Allergy and Asthma Congress 2013 in Milan, Italy.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
American Airlines Group said pilots at its subsidiaries American Airlines and US Airways, represented by Allied Pilots Association, have approved a new five-year contract which provides immediate pay raises of 23 percent and subsequent annual raises of three percent for the next five years. LEGO Group, TT Games and Warner Bros. Interactive Entertainment have announced their 2015 slate of video games, including LEGO Jurassic World, LEGO Marvel's Avengers, and as well as new hand-held and mobile titles. Social-networking giant Facebook, Inc. is said to be testing their new 'Place Tips' feature for iOS users that will rival a similar service being provided by Yelp or Foursquare. The feature will provide the user relevant content about their location as long as they are there through pop ups on their news feed page of Facebook.
comments powered by Disqus
RELATED NEWS
Trade NVS now with 
Follow RTT