Ascendis Pharma A/S on Wednesday said the U.S. Food and Drug Administration approved its Skytrofa as a treatment for Pediatric Growth Hormone Deficiency.
The company said Skytrofa, or lonapegsomatropin-tcgd, is the first once-weekly treatment approved to treat Pediatric Growth Hormone Deficiency.
The company also said Skytrofa was approved to treat "pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone."
The company said the approval includes its Skytrofa Auto-Injector and cartridges, which enable families to store the medicine at room temperature for up to six months.
The company said availability of Skytrofa in the U.S. is expected soon.
Ascendis said it would hold an investor conference call at 4:30 p.m. ET today.
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