Regulatory Decision Summary for Ngenla

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

Product type:


Medicinal ingredient(s):


Therapeutic area:

Human Growth Hormone

Type of submission:

New Drug Submission (NDS)

Control number:

What was the purpose of this submission?


The purpose of this submission was to seek authorization to market Ngenla (somatrogon injection) for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).


Why was the decision issued?


Health Canada considers that the benefit-risk profile of Ngenla (somatrogon injection) is favourable for the long-term treatment of pediatric patients who have growth failure due to inadequate secretion of growth hormone.

The authorization of Ngenla (somatrogon injection) was supported by the results from two open-label, multicentre, active-controlled studies (CP-4-006, and a supportive study CP-4-004). Both studies were conducted in pre-pubertal pediatric patients aged 3 to 11 years at baseline who had growth failure (standing height more than 2 standard deviations lower than average for their age and sex and who were naïve to growth hormone treatments). In CP-4-006, subjects were treated with once-weekly subcutaneous injections of 0.66 mg/kg body weight/week Ngenla (N = 109) or once-daily subcutaneous injections of 0.034 mg/kg body weight/day Genotropin (somatropin injection) (N = 115) for 12 months. The primary efficacy endpoint was height velocity at 12 months in centimeters per year. After 12 months of treatment, mean height velocity was 10.10 centimeters in Ngenla-treated subjects and 9.78 centimeters in Genotropin-treated subjects. The mean increase in height velocity in Ngenla-treated patients met the pre-specified non-inferiority margin of -1.8 centimeters per year and was clinically meaningful. The results of the secondary efficacy endpoints (e.g., height standard deviation score at 12 months and change in height standard deviation score from baseline to 12 months) supported the efficacy profile of Ngenla. In the supportive study CP-4-004, 14 additional subjects were treated with 0.66 mg/kg body weight/week Ngenla or 0.34 mg/kg body weight/day Genotropin and after 12 months, height velocity results were generally consistent with and supportive of those reported in study CP-4-006.

The safety data were derived from studies CP-4-004 and CP-4-006 and comprised a combined total exposure to somatrogon of 476.8 patient-years. The safety profile of Ngenla was not clinically meaningfully different from that of Genotropin, except for injection site reactions, including injection site pain, injection site erythema, injection site pruritus, injection site swelling, injection site induration, injection site bruising, injection site haemorrhage and injection site warmth, which were reported more frequently in Ngenla-treated subjects. These reactions were not associated with hypersensitivity or anaphylactic reactions. 

Overall, the anticipated benefits of Ngenla are expected to outweigh its risks when used under the conditions of use recommended in the Ngenla (somatrogon injection) Product Monograph at this time.

For more information on Health Canadas decision, please view the Summary Basis of Decision.


Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations