Regulatory Decision Summary for BLEXTEN

The efficacy of a single dose of bilastine, 20 mg once-daily (QD) for the treatment of SAR was evaluated in 3  randomized, double-blind, parallel-group, placebo- and active-controlled clinical trials of 14 days duration in adolescent and adult subjects aged 12 years and older with SAR. The primary efficacy endpoint was the Total Symptom Score, which incorporated the reflective Total Nasal Scores (rTNSS), and the reflective Total Non-Nasal Scores (rTNNSS), which were assessed as secondary efficacy end-points, along with quality of life. Two of the pivotal studies have shown efficacy superior to placebo based on the primary and secondary efficacy end-points. Based on the efficacy data from these studies, the efficacy of 20 mg bilastine QD in subjects 12 years of age and older with SAR has been demonstrated.

The efficacy of a single dose of bilastine, 20 mg QD for the treatment of CSU was evaluated in 2 randomized, double-blind, parallel-group placebo controlled clinical trials of 28 days duration in adult subjects aged 18 years and older with CSU. The primary efficacy endpoint was the change in the Total Symptom Score, which incorporated itching intensity, wheals number and maximum size of wheals. These two studies have shown superior efficacy for bilastine over placebo for the primary and secondary efficacy end-points and the efficacy results are considered appropriate at this time to support the indication of bilastine, 20 mg QD for the relief of the symptoms associated with CSU (for example [e.g.], pruritus and hives), in patients 18 years of age and older.

The favorable benefit-risk profile of 20 mg of bilastine administered orally QD is also supported by the safety data from 10 Phase 2 and 3 studies where bilastine was used at doses ranging from 10 - 40 mg over treatment periods of 2 - 4 weeks, and one open-balel long term safety study where 513 patients were treated with bilastine 20 mg QD for up to one year. The benefit-risk profile of 20 mg of bilastine for the treatment of SAR in adolescents and adults 12 years of age and older, and for the treatment of CSU in adult population, 18 years of age and older is considered positive.

An increased risk in patients with hypersensitivity to bilastine or to any ingredient in the formulation, as well as in patients with a history of QT prolongation and/or torsade de pointes, including congenital long QT syndromes has been identified. Health Canada considers the benefit-risk profile of bilastine in these patients as negative. Bilastine is contraindicated in these patient groups.

The approval of bilastine 20 mg once daily for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older and for the relief of the symptoms associated with chronic spontaneous urticaria (CSU) (e.g., pruritus and hives), in patients 18 years of age and older is recommended.