Regulatory Decision Summary for Taltz

The recommendation for authorization was based on the totality of evidence that included a phase 3, randomized, double-blind, placebo-controlled clinical study (RHBX) in patients with nr-axSpA. The study evaluated two dosing regimens and starting doses. Patients were treated with either placebo or Taltz 80 mg or 160 mg at Week 0, followed by either 80 mg every 2 weeks (Q2W) or 80 mg every 4 weeks (Q4W). The primary endpoint was the percentage of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16. Secondary endpoints evaluated efficacy at week 52 as well as additional disease indices and measures of disease activity at weeks 16 and 52.

At week 16, a higher proportion of patients treated with Taltz 80 mg Q4W achieved ASAS40 response compared to placebo at Week 16. Responses were similar regardless of concomitant therapies. Efficacious response was comparable between the Q4W and Q2W groups as well as among different starting doses with no meaningful differences. The improvements were also consistent in reducing signs and symptoms as well as physical function against placebo. The results were statistically significant and clinically meaningful.

The safety profile of Taltz was consistent with previously authorized indications. The study did not identify any new safety signals. The most frequently reported adverse events were injection site reactions and infections. The safety and efficacy of Taltz has not been studied in special populations such as pregnant and breastfeeding women, and geriatric patients.

Overall, benefit-risk profile of Taltz for the treatment of adult patients with active nr-axSpA with objective signs of inflammation who have responded inadequately to, or are intolerant to conventional therapy, is considered favourable.