Health Canada Approves NGENLA (somatrogon) Injection for Pediatric Growth Hormone Deficiency

New Offering Expands Pfizer’s Growth Hormone Portfolio of Rare Disease Drugs and Treatment Options

KIRKLAND, QC, October 29, 2021 /CNW Telbec/ – Pfizer Canada ULC announced that its next-generation long-acting growth hormone injection, PrNGENLA® (somatrogon), has been approved by Health Canada. NGENLA is a once-weekly long-acting recombinant human growth hormone for the long-term treatment of pediatric patients with growth failure due to insufficient secretion of endogenous growth hormone (growth hormone deficiency or GHD).

Pfizer Canada ULC Logo (CNW Group/Pfizer Canada ULC)

NGENLA offers pediatric patients, their loved ones and caregivers a treatment option that reduces treatment frequency for children from daily injections to once-weekly injections.

“We are delighted that Canada is the first country to approve NGENLA,” said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. “Today’s announcement is an important milestone in our effort to provide therapeutic options that can help children reach their full potential.”

GHD is a rare disease characterized by insufficient secretion of growth hormone by the pituitary gland, affecting one in approximately 4,000 to 10,000 children worldwide.1,2 In Canada, this represents approximately 1,600 children.6 Without treatment, affected children will show sustained growth. attenuation and short height in adulthood.3,4 “This is great news for growth hormone deficiency patients across Canada, who now have a different treatment option,” says Dr. Cheri Deal, former chief of pediatric endocrinology at CHU Sainte-Justine in Montreal. “The endocrine community and the patients and families affected by GHD have long waited for a means to reduce the frequency of injections.”

In terms of clinical data, NGENLA Injection has received a notification of compliance (NOC) based on safety and efficacy data from a global Phase 3 study. The somatrogon Phase 3 trial is a randomized, open-label, active-controlled trial conducted in more than 20 countries evaluating the safety and efficacy of NGENLA (somatrogon) injection. This study included and treated 224 previously untreated children with growth hormone deficiency

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“Pfizer Canada is proud to bring this new therapy to Canadians, demonstrating our long-standing commitment to improving care for people with GH disorders,” said Frederick Little, Canada Lead – Rare Disease, Pfizer Canada ULC . “Pfizer’s focus on rare diseases builds on more than two decades of experience, a dedicated research unit focused on rare diseases, and a global portfolio of multiple drugs across a number of disease focus areas, including rare hematologic, neurologic, cardiac and hereditary metabolic diseases.”

In 2014, Pfizer and OPKO entered into a global agreement to develop and commercialize somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for executing the clinical program and Pfizer is responsible for registering and commercializing somatrogon.

About Growth Hormone Deficiency
Growth hormone deficiency is a rare disease characterized by insufficient secretion of growth hormone by the pituitary gland and affects approximately 1,600 Canadian children.1,2,6 In children, this disease can be caused by genetic mutations or acquired after birth.1,5 Because the The patient’s pituitary gland does not secrete sufficient levels of somatropin, the hormone that causes growth, a child’s height may be affected and puberty may be delayed.1,3,4 Without treatment, affected children will have persistent growth retardation and short height in adulthood. age .3.4

About NGENLATM (Somatrogon) Injection
NGENLATM is a glycosylated biological product containing the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains are responsible for the extended half-life of the molecule. In Canada, NGENLATM (somatrogon) Injection is indicated for the long-term treatment of pediatric patients with growth failure due to insufficient secretion of endogenous growth hormone (growth hormone deficiency).

About Pfizer Canada
Pfizer Canada ULC is the Canadian subsidiary of Pfizer Inc., one of the world’s leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world’s best-known and most widely prescribed drugs and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. For more information about Pfizer Canada, visit pfizer.ca or follow us on LinkedIn, Facebook, Twitter or YouTube.

About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company seeking to establish leadership positions in large, high-growth markets by leveraging its discovery, development and commercialization expertise and new and proprietary technologies. For more information, visit http://www.OPKO.com.

1. National Organization for Rare Disorders. Growth hormone deficiency. https://rarediseases.org/rare-diseases/growth-hormone-deficiency/. Accessed February 5, 2021.

2. Stanley T. Diagnosis of growth hormone deficiency in childhood. Curr Opin Endocrinol Diabetes Obesity. 2012;19(1):47-52. doi:10.1097/MED.0b13e32834ec952.

3. Grimberg A, DiVall S, A, Polychronakos C, Allen D, B, Cohen L, E, Quintos J, B, Rossi W, C, Feudtner C, Murad M, H: Growth Hormone and Insulin-Like Growth Factor Guidelines -I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature and primary insulin-like growth factor I deficiency. Horm Res Paediatr 2016;86:361-397. doi: 10.1159/000452150

4. Ergun-Longmire B, Wajnrajch M. Growth and growth disorders. Feingold KR, Anawalt B, Boyce A, et al., eds. endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000. Available at: https://www.ncbi.nlm.nih.gov/books/NBK279142/

5. Cerbone M, Dattani MT. Progression from isolated growth hormone deficiency to combined pituitary hormone deficiency. Growth Hormone IGF Res. 2017;37:19-25. doi:10.1016/j.ghir.2017.10.005.

6. DRG

7. A Phase 3, Open-Label, Randomized, Multicenter, 12-Month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Prepubescent Growth Hormone Deficient Children

SOURCE Pfizer Canada ULC

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