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Somatrogon: First Approval

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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.

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Yvette N. Lamb

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  1. Yvette N. Lamb
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Correspondence to Yvette N. Lamb.

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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.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Lamb, Y.N. Somatrogon: First Approval. Drugs 82, 227–234 (2022). https://doi.org/10.1007/s40265-021-01663-2

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  • DOI: https://doi.org/10.1007/s40265-021-01663-2

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