The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
The CHMP has recommended 300mg dose by subcutaneous injection every four weeks.
CSU, also known as chronic idiopathic urticaria (CIU) in the US, 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.
Novartis Pharmaceuticals global head of development Tim Wright noted this positive news from the CHMP brings the company one step closer to providing an innovative therapeutic option from its specialty dermatology portfolio to people suffering from this chronic and debilitating disease.
"If approved, Xolair will be the first and only licensed therapy in the EU for up to 50% of CSU patients not responding to approved doses of antihistamines," Wright added.
CHMP has issued positive opinion based on positive and consistent results from three pivotal Phase III registration studies (Asteria I, Asteria II and Glacial). Xolair is a targeted therapy that binds to immunoglobulin E (IgE).
The three pivotal Phase III studies have evaluated the efficacy and safety of Xolair in nearly 1,000 CSU patients not responding to antihistamines
Results from the three pivotal registration studies for Xolair in CSU were announced in 2013.
Xolair 300mg has met all primary and pre-specified secondary endpoints across these studies, which showed the drug significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.
In these studies, the incidence and severity of adverse events were similar between Xolair and placebo recipients.
Novartis and Genentech are jointly developing Xolair for CSU.
The drug has already obtained approval for the treatment of CSU in Egypt, Turkey, Guatemala and El Salvador, and regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland.