Novartis Receives NMPA Approval for Omalizumab New Indication in Chronic Spontaneous Urticaria

Source: PharmaCube Info

On April 13, Novartis' omalizumab received approval from the National Medical Products Administration for a new indication, presumed to be for the treatment of antihistamine-refractory chronic spontaneous urticaria (CSU).

Omalizumab is a recombinant humanized monoclonal antibody, an anti-IgE targeted biologic agent. It was first approved in China in August 2017 for use in adult and adolescent patients (12 years and older) with moderate to severe persistent allergic asthma whose symptoms are not adequately controlled after treatment with inhaled corticosteroids and long-acting inhaled β2-adrenergic receptor agonists.

In March 2021, Novartis announced positive results from the Phase III study in China of omalizumab for the treatment of Chronic Spontaneous Urticaria (CSU). This is the first targeted biologic study conducted specifically for Chinese CSU patients. The Phase III study was designed as a multicenter, randomized, double-blind, placebo-controlled trial, enrolling 418 Chinese patients to evaluate the efficacy and safety of omalizumab at doses of 150mg and 300mg in Chinese CSU patients.

In this Phase III clinical trial in China, both the 150mg and 300mg omalizumab groups reached the primary endpoint: after 12 weeks of treatment, both significantly reduced patients' weekly itch severity. Regarding secondary endpoints: compared with the placebo group, the omalizumab treatment group showed a significant reduction in disease activity at week 12. Patients' quality of life was effectively improved, with overall good tolerability and safety.

As a common chronic skin disease, the typical manifestations of Chronic Spontaneous Urticaria (CSU) include wheals or angioedema without specific external triggers, accompanied by itching and/or pain. The course of the disease typically lasts 2-5 years, with 10% of patients experiencing a course lasting more than 5 years, and some even exceeding 25 years. CSU significantly impacts multiple aspects of patients' quality of life, including work, daily activities, and sleep, and is often associated with autoimmune, infectious, and psychiatric disorders, imposing a heavy socioeconomic and family burden. Currently, antihistamines are the only treatment approved for CSU in China, but still, one-quarter to one-third of patients cannot achieve effective control.