Novo Nordisk's Long-Acting Growth Hormone Sogroya Receives CHMP Positive Opinion for Pediatric Use

May 27, 2023 08:39 CST Updated 08:39

Novo Nordisk

Insulin Developer and Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On May 26, Novo Nordisk's official website announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the marketing authorization for the long-acting growth hormone Sogroya (somapacitan), intended for the treatment of growth hormone deficiency in children aged 3 years and older.

The active pharmaceutical ingredient of Sogroya is somapacitan, which is a long-acting analog of human growth hormone (hGH). Somapacitan is modified from natural hGH to enhance its binding to albumin, making it suitable for once-weekly administration.

The CHMP recommendation this time is based on data from the Phase III REAL4 study. The REAL4 study is a multicenter, randomized, open-label Phase III trial designed to evaluate the efficacy and safety of Sogroya in treating growth hormone deficiency in prepubertal children. In the REAL4 study, patients were randomly assigned in a 2:1 ratio to receive either once-weekly subcutaneous injections of Sogroya at 0.16 mg/kg (n=132) or daily subcutaneous injections of Norditropin at 0.034 mg/kg (n=68).

The study showed that patients receiving once-weekly Sogroya treatment had an annualized growth rate of 11.2 cm/year, which was not significantly different from the 11.7 cm/year observed in patients treated with once-daily Norditropin, thereby meeting the primary endpoint of non-inferiority. Additionally, Sogroya was well-tolerated, with safety and tolerability similar to Norditropin.

The European Commission (EC) will review the CHMP’s positive opinion and is expected to make a final decision on the marketing authorization of Sogroya in the coming months. If approved, Sogroya will become available in some European countries starting from the fourth quarter of 2023.

Sogroya was initially approved by the FDA on September 1, 2020, for the treatment of adult growth hormone deficiency. In April 2023, the FDA expanded the indication for Sogroya to include the treatment of growth hormone deficiency in children aged 2.5 years and older.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

PharmaCube Reader Survey Questionnaire

Thank you for your companionship. Looking forward to your feedback.

Scan the QR code to provide valuable suggestions