Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

6/26/2013 1:32 AM ET

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

Editors Pick
Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter. Stocks moved mostly lower during trading on Wednesday, giving back some ground after trending higher over the past several sessions. Selling pressure was relatively subdued, however, limiting the downside for the markets. The major averages all closed in the red, although the tech-heavy Nasdaq underperformed its counterparts by a wide margin. Russian Foreign Minister Sergei Lavrov warned Wednesday that Moscow would retaliate strongly if its "interests" in Ukraine are attacked. He also criticized the Ukrainian administration for relaunching its so-called anti-terrorist operation in the east of the country a day earlier. Lavrov's remarks came in an interview with Russia Today, which published excerpts of the English-language interview to
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.