Novartis has presented late-stage data on omalizumab, already approved for asthma and sold as Xolair, which shows that it significantly improved itch in patients with a debilitating form of hives.
Results have been published from the second of three Phase III studies looking at the drug as a treatment for chronic spontaneous urticaria, a chronic form of hives with limited approved treatment options. Up to 40% of CSU patients fail on antihistamines, the only approved treatments, even those taking up to four times the approved dose.
The data found that more than one third of patients with CSU treated with omalizumab were completely itch and hive-free after 12 weeks compared to 5% of those on placebo. During the same time period, the proportion of patients with well-controlled CSU symptoms was four times higher in the omalizumab group compared to placebo (52% vs 12% respectively) and the improvements were sustained up to week 24.
Up to 80% of patients with CSU suffer negative effects, including sleep deprivation and psychological comorbidities such as depression and anxiety, Novartis said, noting that patients receiving omalizumab experienced nearly double the improvement in a quality of life measure. They also had a significant increase in the proportion of days free of deep tissue swelling (angioedema), a painful and disfiguring condition experienced by 40%-50% of patients with CSU.
Omalizumab is being jointly developed for CSU by Novartis and Roche's Genentech unit and regulatory submissions are on track for later this year.