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Pfizer’s and OPKO Health’s Growth Hormone Therapy Receives FDA Review

January 6, 2021

The FDA has accepted Pfizer’s and OPKO Health’s biologics license application for somatrogon for treating pediatric patients with growth hormone deficiency.

The agency has set a target date of October 2021 to give a decision on the long-acting investigational human growth therapy for growth hormone deficiency in pediatric patients.

The once-a-week therapy “could help reduce the burden of daily growth hormone injections on children, their loved ones and caregivers,” said Brenda Cooperstone, Pfizer’s chief development officer for rare diseases.

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