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) 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
10 Worst Places To Raise A Family Whether you are a young couple building a nest or seasoned parents looking for a change of scenery, there are number of places around the country that should be avoided, according to personal finance website WalletHub. They looked at mainly five categories for... A passenger has filed a lawsuit against Canadian budget airline Sunwing Airlines for serving him cheap sparkling wine instead of champagne on board a flight, according to media reports. The Canadian passenger, Daniel MacDuff, reportedly boarded his Sunwing flight to Cuba in February, on a flight package that advertised a complimentary on-board champagne toast. Senate Health Committee Chairman Lamar Alexander, R-Tenn., and ranking member Patty Murray, D-Wash., announced Thursday that twenty-two other Senators are cosponsoring their bipartisan plan to provide short-term stability to Obamacare. The bipartisan bill includes a two-year extension of the cost-sharing...
comments powered by Disqus
Follow RTT