Regulatory Decision Summary for Cosentyx

• Plaque psoriasis is a chronic inflammatory skin condition, usually characterized by pruritic erythematous patches, flaking, and scales. Psoriasis has a broad impact on patients that extends beyond the cosmetic or physical aspects. It can negatively affect a person’s quality of life due to physical pain and discomfort, which can interfere with sleep and the ability to engage in daily activities, and can have an impact on mental health.

• Authorization of Cosentyx was based on two studies. One was a randomized, double-blind, placebo and active controlled multicenter trial with efficacy and safety data up to week 52 in pediatric patients from 6 to less than 18 years old with severe plaque psoriasis. The other was an open-label, multicenter study with efficacy and safety data up to week 24 in patients 6 to less than 18 years old with moderate-to-severe plaque psoriasis. Cosentyx was administered by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. Patients randomized to the Cosentyx treatment arms received either a low dose or a high dose of Cosentyx, based on weight category.

• The benefits of Cosentyx are demonstrated by an assessment of clinical response using two co-primary endpoints that measure disease severity: the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA mod 2011). In both studies, the key co-primary endpoints were measured as the PASI 75 response at week 12, and IGA mod 2011 0 or 1 response at week 12. All co-primary endpoints were achieved, and a favourable treatment effect was consistently observed in both studies.

• The most common adverse reactions reported in ≥5% of patients during treatment with Cosentyx included nasopharyngitis (23.2%), headache (9.6%), pharyngitis (7.6%), diarrhea (5.6%), rhinitis (5.6%), upper respiratory tract infection (5.6%), abdominal pain (5.1%), abdominal pain upper (5.1%), acne (5.1%), and cough (5.1%). These safety observations do not indicate any clinically meaningful differences from the well-established safety profile of Cosentyx.

• The recommended dose of Cosentyx in pediatric patients is 75 mg for patients ≥6 years old weighing <50 kg. The recommended dose of Cosentyx in pediatric patients is 150 mg for patients ≥6 years old weighing ≥50 kg, which can be increased to 300 mg as needed. Cosentyx is administered as a subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by a subcutaneous injection every 4 weeks. Please view the product monograph for further details.

Overall, the anticipated benefits of Cosentyx are expected to outweigh its risks when used under the conditions of use recommended in the Cosentyx product monograph at this time.