Regulatory Decision Summary for RUPATADINE

The efficacy of a single dose of Rupatadine 10 mg tablet for the treatment of SAR and PAR was evaluated in two randomized, double-blind, parallel-group, placebo- and active-controlled clinical trials of 4-week (SAR) and 12-week (PAR) duration in adolescent and adult subjects, ages 12 years and older. The primary efficacy endpoint was the Total Symptom Score, which incorporated the Total Nasal Scores (TNSS), and the Total Non-Nasal Scores (TNNSS). Additional parameters, such as quality of life parameters were also examined. Both 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 10 mg Rupatadine once daily (QD) in subjects 12 years of age and older with SAR and PAR has been demonstrated.

The efficacy of a single dose of Rupatadine, 10 mg tablet QD for the treatment of CSU was evaluated in two randomized, double-blind, parallel-group placebo controlled clinical trials, one of 4 weeks and one of 6 weeks duration in adults and adolescents aged 12 years and older with CSU. The primary efficacy endpoint was the change in the Mean Pruritus Score (MPS). Based on the efficacy data from these studies, the efficacy of 10 mg Rupatadine tablets QD in subjects 12 years of age and older with CSU has been demonstrated.

The efficacy of Rupatadine oral solution (1 mg/mL), in children 2-11 years of age with allergic rhinitis and CSU has been demonstrated in two pivotal trials (one study in children 6-11 years of age with allergic rhinitis, and 1 study in children 2-11 years of age with CSU). Efficacy of Rupatadine oral solution in children 2-5 years of age with allergic rhinitis was extrapolated based on PK and safety data from a dedicated study.

Most common adverse events included headache and somnolence.

The benefit-risk profile of Rupatadine for the treatment of allergic rhinitis in children, adolescents and adults 2 years of age and older, and for the treatment of CSU in children, adolescents and adults 2 years of age and older is considered positive.

Rupatadine 10 mg tablets are indicated for adolescents and adults; 12 years of age and older.

Rupatadine oral solution (1 mg/mL) at a dose of 2.5 mL is indicated for children of ≥10 kilograms (kg) up to <25 kg (mainly 2-5 years of age).

Rupatadine oral solution (1 mg/mL) at a dose of 5 mL is indicated for children ≥25 kg (mainly 6-11 years of age).

Rupatadine should not be taken by patients with hypersensitivity to Rupatadine or to any ingredient in the formulation. Rupatadine should not be taken by patients with a history of QT prolongation and/or torsade de pointes, including congenital long QT syndromes, as well as in patients treated with Cytochrome P450 3A4 (CYP3A4) inhibitors or other QTc-prolonging drugs. Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, glucose-galactose malabsorption or the Lapp lactase deficiency should not take Rupatadine tablets. Due to the presence of sucrose, patients with rare hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase insufficiency should not take Rupatadine oral solution. Health Canada considers the benefit-risk profile of Rupatadine in these patients as not acceptable. Rupatadine is contraindicated in these patient groups.

Treatment with Rupatadine QD for the symptomatic relief of nasal and non-nasal symptoms of SAR and PAR in patients 2 years of age and older, and for the relief of the symptoms associated with CSU (e.g. pruritus and hives), in patients 2 years of age and older is considered to have a favourable risk-benefit profile.