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
Electric car maker Tesla Motors Inc. (TSLA), Wednesday reported a profit for the third quarter beating Wall Street estimates by a large margin, driven primarily by record production and deliveries. Shares of the company gained over 5 percent in extended hours after the company reaffirmed its delivery... Auvi-Q, the rival for EpiPen, will be coming back in 2017, pharmaceutical company Kaleo announced on Wednesday. Auvi-Q is a epinephrine injection used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. Auvi-Q... Uber's self-driving technology start-up Otto has partnered with Anheuser-Busch InBev to complete the world's first shipment by a self-driving truck. Otto said in a blog post that the company and Anheuser-Busch delivered 51,744 cans of Budweiser beer from Fort Collins, through downtown Denver, to Colorado Springs.
comments powered by Disqus
Follow RTT