October 07 ,2013 | By Márcio Barra
Xolair (Omalizumab), Novartis Humanized monoclonal IgG anti-IgE antibody for the treatment of moderate to severe persistent asthma, might be heading towards a new therapeutic indication, according to data from a recent trial.
The trial, ASTERIA 1, the last of a series of phase III studies (following GLACIAL and ASTERIA II), showed that the drug is both safe and effective in treating chronic spontaneous urticaria, a chronic condition characterised by red, swollen, itchy and sometimes painful hives or wheals on the skin that can occur without warning and can last for weeks on end. The current approved treatment for this condition consists only of high dosages of antihistamines, with generally limited efficacy.
The study enrolled a total of 318 patients, who were randomized to omalizumab 300 mg, 150 mg, 75 mg or placebo (1:1:1:1). Patients treated with omalizumab 300mg responded as early as week 1 versus week 4 in the placebo group. By week 12, all three doses of the drug (300mg, 150mg and 75mg) showed significant improvements over placebo in improving patients’ weekly Itch Severity Score (ISS), the primary endpoint of the study. The alleviation of itch was sustained over 24 weeks.
Findings also showed that patients treated with 300 mg omalizumab experienced nearly twice the improvement in their quality of life compared to those taking placebo by week 12. 52% of this dose group had their chronic spontaneous urticaria symptoms well controlled and 36% had no symptoms at all. Quality of life is an especially important measure when assessing chronic spontaneous urticaria treatments, because the disease can frequently lead to sleep deprivation, depression and anxiety.
Omalizumab, under the brand name Xolair, is currently approved for the treatment of moderate to severe persistent allergic asthma in the US since 2003 and the EU since 2005 (in Portugal, the drug is sold since 2006). As an asthma treatment, Xolair has been a successful product for Novartis, with sales booked by the company and US marketing partner Genentech crossing the 1 billion plus barrier in 2011, and sales of $289m in the first six months of 2013, an increase of 21% on the same period of 2012. Due to its IgE reduction effect, the drug has potential for additional clinical indications, which could help offset the drug’s high price (around $500 to $2,000 per month, depending on dose).