Positive phase 3 data for Novartis’ skin disease drug
Positive phase 3 clinical trial results for Novartis’ skin disease drug, omalizumab, have been announced.
The ASTERIA 1 study showed that omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU), which is a persistent and debilitating form of hives.
“The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50% of patients don’t respond to approved doses of antihistamines, the only licensed treatment option. With submissions to EU and US regulatory authorities now completed, we are on track to bring omalizumab to people suffering from this chronic and debilitating disease.”
Tim Wright, Global Head of Development, Novartis Pharmaceuticals.
Omalizumab is currently not approved for the treatment of CSU.
Novartis filed regulatory applications for omalizumab in CSU in the US and EU in the third quarter of 2013. The applications were based on positive data from ASTERIA 1, as well as two other phase 3 clinical trials, ASTERIA 11 and GLACIAL.
Results were presented at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey.
CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and re-occur for more than six weeks.
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