Regulatory Decision Summary for Taltz

Authorization was based on two pivotal phase 3 trials (RHBV and RHBW). These were randomized, double-blind, placebo-controlled, multicenter studies with blinded treatment period of 16 weeks. Within the context of this submission, 639 patients with ankylosing spondylitis were exposed to Taltz 80 mg every 4 weeks with a starting dose of either 80 mg or 160 mg.

The primary efficacy endpoint was the percentage of patients achieving ASAS40 (greater than or equal to 40% improvement and an absolute improvement from baseline in three or more domains of patient global, spinal pain, function and inflammation) at week 16. The data from the pivotal studies demonstrated statistically significant difference in the proportion of patients receiving Taltz compared to placebo. In study RHBV, 48.1% and 18.4% of patients achieved ASAS40 response in the Taltz and placebo groups, respectively. In study RHBW, 25.4% and 12.5% of patients achieved ASAS40 response in the Taltz and placebo groups, respectively. The response difference of active treatment to placebo was statistically significant and clinically meaningful in both studies.

The safety profile of Taltz was found to be consistent with previously authorized indications. The most common adverse events were injection site reactions, upper respiratory tract infections, tinea infection, rhinitis, and oropharyngeal pain. These adverse drug reactions are labelled in the Canadian Product Monograph for the safe use of the product.

Overall the benefit-risk profile of Taltz for the treatment of adults with ankylosing spondylitis was considered favourable. The recommended dose of Taltz is 80 mg every 4 weeks as included in the Canadian Product Monograph.