Regulatory Decision Summary for Sogroya

The purpose of this New Drug Submission (NDS) was to gain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Sogroya, submitted by Novo Nordisk Canada Inc.

This New Drug Submission was filed to obtain market authorization of the following indication which was approved:

Sogroya (somapacitan injection) is indicated for:

• The long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (Growth Hormone Deficiency [GHD]).

• The replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).

Growth hormone (GH) deficiency (GHD) is a rare disorder which affects both children and adults. It is characterised by inadequate systemic availability of GH due to inadequate secretion from the anterior pituitary gland or destruction of the gland. Sogroya (somapacitan) is a long-acting human GH intended for once-weekly administration.

Authorization was based on two pivotal trials. In adults, REAL 1 (study 4054) was an active- and placebo-controlled study that included treatment-naïve patients aged 23 years or older. In pediatrics, Study 4263 (REAL 4) was an active-controlled open label pivotal Phase 3a study in pediatric GHD patients. In adult GHD patients, Sogroya was demonstrated to be superior to placebo in the primary endpoint of truncal fat percentage at Week 34. In pediatric GHD patients, non-inferiority of Sogroya to Norditropin Flexpro was demonstrated for the primary endpoint of height velocity at Week 52.

The most common (≥5%) adverse events (AEs) in adult subjects treated with Sogroya in the pivotal study, and more frequently than in placebo treated patients through 34 weeks were: back pain (10%), arthralgia (6.7%) and dyspepsia (5.0%). The most common (≥5%) AEs in pediatric subjects treated with Sogroya in the pivotal study 4263, and more frequently than in the Norditropin group through 52 weeks of treatment were: headache (12.1%), nasopharyngitis (11.4%), and pain in extremity (9.1%). The majority of AEs were of mild or moderate severity, with few serious adverse events.

Overall, the anticipated benefits of Sogroya are expected to outweigh its risks when used under the conditions of use recommended in the Sogroya Product Monograph. Health Canada considers the benefit-risk profile of Sogroya to be favourable for the proposed indications: the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone; and the replacement of endogenous growth hormone in adults with GHD.

An updated Risk Management Plan (RMP) for Sogroya was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Sogroya has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

The overall, the benefit-harm-uncertainty profile is favourable for Sogroya and 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL for the recommended indication. A Notice of Compliance (NOC) was issued.

For further details about Sogroya, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.