Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade NVS now with 

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.

Register
To receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Here is a quick summary of the earnings reported after the bell on Nov 19. Keurig Green Mountain, Inc. (GMCR) reported net income for the fourth quarter of $141.1 million or $0.86 per share, compared to $127.0 million or $0.83 per share for the year-ago quarter. Excluding items, adjusted net... Women's apparel retailer L Brands, Inc. said Wednesday that its third quarter profit rose 43% from last year, as sales increased 7%. The company's quarterly earnings per share also came in above analysts' expectations. At the same time, the company forecasts fourth quarter earnings below analysts' current consensus estimate, but once again raised its full year earnings outlook. PetSmart, Inc. said Tuesday after the markets closed that its third quarter profit remained essentially flat with last year, as higher costs and expenses offset a 2.6% increase in sales. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly sales.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.