Reduce the number of injections per year by 86%. Long-acting growth hormone therapy is approved by the US FDA

Ascendis Pharma announced today that the U.
S.
FDA has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of children over one year old, weighing at least 11.
5 kg, and suffering from growth disorders due to insufficient endogenous growth hormone (GH) secretion
.

The press release pointed out that Skytrofa is the first US FDA-approved product to deliver growth hormone within a week through sustained release as an injection once a week
.

Growth hormone deficiency (GHD) is a serious and rare disease characterized by short stature and metabolic complications
.

The approval includes the new Skytrofa auto-injector, which allows families to store the medicine at room temperature for up to 6 months after being removed from the refrigerator for the first time
.

The US FDA's approval is based on the results of the phase 3 clinical trial heiGHt, which is a randomized, open-label, active controlled trial that compared weekly Skytrofa with daily growth hormone therapy in 161 GHD-naïve children Effect
.

At week 52, the difference in annual height growth rate (AHV) between groups was 0.
9 cm/year (Skytrofa was 11.
2 cm/year, and daily growth hormone was 10.
3 cm/year)
.

Reference materials:

[1] Ascendis Pharma A/S Announces US Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency.

(The original text has been deleted)