Regulatory Decision Summary for Increlex
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.
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What was the purpose of this submission?
The purpose of this submission is to obtain marketing authorization for Increlex (mecasermin) for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD). After evaluation of the submitted data package, Health Canada authorized the following indication: Increlex (mecasermin) is indicated for the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD).
Why was the decision issued?
The authorization was mainly based on a pivotal Study 1419 in 92 pediatric subjects with SPIGFD and Real World Evidence. Increlex was effective in increasing height and height velocity (HV) compared to baseline height and HV in patients with SPIGFD.
The most common side effects of Increlex included hypoglycemia (low blood sugar). Increlex may cause serious allergic reactions (anaphylaxis) and may increase risk of tumours (both cancerous and non-cancerous) in children and adolescents. Other side effects included injection site reactions, enlarged tonsils/adenoids, increased pressure in the brain (intracranial hypertension), a bone problem called slipped capital femoral epiphysis, worsened scoliosis and enlarged organs. Increlex should be used according to the recommended dose and specific precautions included in the approved Product Monograph to manage the risk with Increlex.
Increlex is injected just under the skin shortly before or after a meal or snack. The recommended dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day.
Increlex fulfils an unmet therapeutic need due to the benefits in increasing growth in patients with SPIGFD and the lack of alternative treatment options. Increlex has an acceptable benefit/risk profile for the treatment of SPIGFD if used according to the approved Product Monograph.
View the Increlex PM for more information.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| INCRELEX | 02509733 | IPSEN BIOPHARMACEUTICALS CANADA INC | MECASERMIN 40 MG / 4 ML |