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.