Pfizer and OPKO provide update on the biologics license application for somatrogon for paediatric growth hormone deficiency

Pfizer

21 January 2022 - Pfizer and OPKO Health announced today that the U.S. FDA issued a complete response letter for the biologics license application for somatrogon. 

Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency in paediatric patients. 

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics