| Clinical data | |
|---|---|
| Trade names | Ngenla |
| Other names | MOD-4023, somatrogon-ghla |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623041 |
| License data | |
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Somatrogon, sold under the brand nameNgenla, is amedication for thetreatment ofgrowth hormone deficiency.[1][6][8] Somatrogon is a glycosylatedprotein constructed fromhuman growth hormone and a small part ofhuman chorionic gonadotropin which is appended to both theN-terminal andC-terminal.[8] Somatrogon is a human growth hormone analog.[6]
The most common side effects include reactions at the site of injection, headache, and fever.[7]
Somatrogon was approved for medical use in Australia in November 2021,[1] in the European Union in February 2022,[7] and in the United States in June 2023.[6][9][10]
Somatrogon isindicated for the treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.[6][9]
The USFood and Drug Administration (FDA) approved somatrogon based on one clinical trial (NCT02968004) of 224 children with growth hormone deficiency and short stature.[9] The trial was conducted at 84 sites in 24 countries including Argentina, Australia, Bulgaria, Belarus, Canada, Colombia, Germany, Georgia, Greece, India, Israel, Italy, Mexico, New Zealand, Poland, South Korea, Russia, Spain, Taiwan, Turkey, Ukraine, the United Kingdom, Vietnam, and the United States.[9] This trial was used to assess efficacy and safety.[9] The benefits and side effects were evaluated in a clinical trial.[9] Children aged 3 to 12 years old were assigned at random to weekly somatrogon or another daily approved growth hormone for 52 weeks.[9]
In December 2021, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ngenla, intended for the treatment ofgrowth hormone deficiency in children and adolescents from three years of age.[11] The applicant for this medicinal product is Pfizer Europe MA EEIG.[11] Somatrogon was approved for medical use in the European Union in February 2022.[7][12]
Somatrogon is theinternational nonproprietary name.[13]
This article incorporates text from this source, which is in thepublic domain. | Thishormonal preparation article is astub. You can help Wikipedia byexpanding it. |
