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
Bond management titan Bill Gross has filed suit against his former employer, PIMCO, for breach of contract related to his ouster from the company. Gross is looking for damages of at least $200 million for forcing him out of the company, according to court filings. Gross claims that other managers conspired to push him out of the firm he co-founded in order to improve their own finances. Large U.S. companies are holding trillions of dollars overseas in an effort to avoid U.S. taxes, with big-name firms like Apple (AAPL), Pfizer (PFE) and PepsiCo (PEP) named as notable examples. This is the claim made by a pair of non-profit groups, who released a study based on the firms' financial statements. Alcoa Inc. (AA), the largest producer of aluminum in the US, Thursday reported a sharp decline in profit for the third quarter, as sales dropped 11 percent reflecting divestitures and currency headwinds. Both the earnings and revenues fell short of Wall Street analysts' estimates, sending its shares...
comments powered by Disqus
Follow RTT