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

 Last Update: 2021-10-11
 Source: Internet
 Author: User

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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
.

In GHD patients, the pituitary gland cannot produce enough growth hormone, which is not only important for height, but also for the child's overall endocrine health and development

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
.

Switching patients from daily injections to weekly injections can reduce the number of injection days per year by up to 86%

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)
.

In this trial, Skytrofa reached the primary endpoint of AHV non-inferiority with similar safety

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.

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