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

The U.S. Food and Drug Administration has granted approval to Pfizer and OPKO Health's treatment for growth hormone deficiency in children. The injectable hormone therapy, known as Ngenla, will be sold under the brand name Ngenla and is intended for pediatric patients aged three years and older. The once-weekly injection will be priced at around $8,300 per month. Pfizer plans to offer benefits to reduce out-of-pocket costs and improve access to the drug, which is expected to be available in the U.S. in August. Ngenla will compete with Ascendis Pharma's once-weekly growth hormone injection, Skytrofa, which was approved by the FDA in 2021.