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
US Steel Corp. (X) Tuesday said it will "adjust operations" and temporarily idle a part of its Minntac plant in Mt. Iron, Minnesota, effective June 1. According to reports, the move would see about 700 employees laid off. The company said the decision was due to its current inventory levels and ongoing... Hewlett-Packard Co. (HPQ) has filed a lawsuit against Michael Lynch, the co-founder of Autonomy Corp., and its former Financial Chief Sushovan Hussain for a whopping $5.1 billion alleging that the executives misrepresented the financial situation of Autonomy. An HP's spokeswoman confirmed that the... Nine acres of green grass with 400 trees and a half-mile-long walk way. We are not talking about any park, but the expansive rooftop of Facebook's new office. The 430,000 square feet office is a single room and it might be the largest open floor plan in the world.
comments powered by Disqus
RELATED NEWS
Trade NVS now with 
Follow RTT