Novartis’ new CSU therapy shows further benefits in new trial

Novartis has presented encouraging results from a new phase III trial of omalizumab, its promising new therapy for chronic spontaneous urticaria (CSU), a debilitating form of hives.

Data from the Asteria I study showed that the drug was able to significantly reduce itching and hives caused by CSU within a week of treatment commencing in some cases, with benefits being sustained over 24 weeks of active therapy.

It was also twice as effective in improving patients' quality of life within 12 weeks of treatment than placebo, backing up the findings of the previous Asteria II and Glacial trials.

Omalizumab has now been studied among nearly 1,000 patients and has demonstrated a strong safety and efficacy profile.

Tim Wright, global head of development at Novartis Pharmaceuticals, said: "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."

Data from the Glacial study reported in June 2013 showed that omalizumab was effective, safe and well tolerated in refractory CSU patients, including those on antihistamines at up to four times the approved dose.