FDA Approves Pfizer-OPKO's NGENLA™ for Pediatric Growth Hormone Deficiency and Alopecia Areata

Pfizer and OPKO Health have received approval from the U.S. Food and Drug Administration for their treatment for growth hormone deficiency in children. The once-weekly injectable hormone therapy, sold under the brand name Ngenla, will be available in the U.S. in August. The approval lifted Pfizer's shares marginally and Opko Health's nearly 19% in premarket trading. Ngenla will compete with Ascendis Pharma's once-weekly growth hormone injection, Skytrofa, which was approved by the FDA in 2021.