Novartis (NVS) recently announced positive results from the phase III GLACIAL study (n=335) on Xolair (omalizumab) for the treatment of patients suffering from refractory chronic spontaneous urticaria (CSU).
The GLACIAL study evaluated the safety and efficacy of Xolair in patients (aged between 12 and 75 years) suffering from moderate-to-severe refractory CSU in comparison to placebo. These patients had earlier received standard-of-care therapy, including concomitant H1 antihistamine therapy (up to four times the approved dose) and other background medications like H2 antihistamines and/or leukotriene receptor antagonists.
Results from the study showed that while over a third of the enrolled patients treated with Xolair were totally itch- and hive-free by the end of week 12, only 5% of the patients under placebo experienced a similar relief. Moreover, the proportion of patients with well-controlled CSU symptoms was also found to be high in the Xolair arm compared to the placebo group. The improvements observed at the end of week 12 were also maintained at the end of week 24. Other key points such as quality of life measure and the proportion of days free of deep tissue swelling were also higher under Xolair compared to placebo. Data from the study also revealed that treatment with Xolair was safe and well tolerated by the patients.
We note that this is Novartis’ second clinical phase III study on Xolair in patients suffering from CSU. In Feb 2013, Novartis reported results from the first phase III trial (ASTERIA II: n=323) on Xolair for the CSU indication. The study met the primary endpoint in two of the three dosage groups studied, revealing that Xolair when administered every four weeks led to a significant improvement in the mean weekly itch severity score from baseline.
Xolair is already approved to treat patients with moderate–to-severe persistent allergic asthma caused by year-round allergens in the air. Novartis intends to seek regulatory approvals of the drug for the CSU indication later in the year. Novartis mentioned in its press release that there is no approved therapy for CSU in over 50% of patients who fail to respond to antihistamines.
Successful development and subsequent commercialization of Xolair for the additional indication should increase its sales potential. Novartis is co-developing Xolair for the CSU indication with Roche (RHHBY).
We are encouraged by Novartis’ recent pipeline progress. Novartis currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals (JAZZ) and Novo Nordisk (NVO) look well placed. While Jazz Pharma carries a Zacks Rank #1 (Strong Buy), Novo Nordisk currently carries a Zacks Rank #2 (Buy).
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