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) 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

Quick Facts

Editors Pick
Airbus Group SE plans to test a prototype for a self-piloted flying car by the end of 2017, Reuters reported, citing the aerospace group's chief executive officer Tom Enders. In order to alleviate urban congestion and to address the rising concern of rush-hour traffic, Airbus is looking skywards to develop three ambitious projects. Luxury coat maker Canada Goose Inc. Is reportedly planning for an initial public offering or IPO within next three months. The Toronto based winter-apparel maker aims for a valuation of up to $2 billion and to raise up to $300 million through IPO. France-based optical-lens maker Essilor International SA (EL), Delfin and Ray-Ban maker Luxottica Group (LUX) Monday announced their plan to merge in a deal valued around $49 billion. Essilor would become a holding company with the new name "EssilorLuxottic."
comments powered by Disqus
Follow RTT