Somatrogon: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate and consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here

Abstract

Somatrogon (NGENLA^®), a long-acting human growth hormone based on C-terminal peptide technology, is in development by Pfizer and OPKO Health for the treatment of growth hormone deficiency in pediatric and adult patients. Administered as a once-weekly subcutaneous injection, somatrogon reduces treatment burden relative to once-daily human growth hormone therapy while providing non-inferior efficacy. Somatrogon received its first approval in October 2021 in Canada for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency). This article summarizes the milestones in the development of somatrogon leading to this first approval for the treatment of growth hormone deficiency.

© Springer Nature Switzerland AG 2021