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Pfizer and Opko Health announce the extension of the PDUFA date for review of somatrogon.

Read time: 1 mins
Last updated:12th Oct 2021
Published:28th Sep 2021
Pfizer Inc. and OPKO Health Inc. announced that the FDA has extended the review period for the Biologics License Application (BLA) for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD) in pediatric patients.

The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer’s submission of additional data to the original BLA.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.

Condition: Growth Hormone Deficiency
Type: drug

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