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Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported in a multi-center, randomized, open-label, active-controlled Phase 3 study (NCT 02968004). Under the agreement, OPKO is responsible for registering and commercializing NGENLA for the treatment of pediatric patients with any evidence of progression or recurrence of an allergic reaction to somatrogon-ghla or any of the clinical program and Pfizer is responsible. The only treatment-related adverse event that occurred in more than 1 patient was joint pain.

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