(RTTNews) - Ascendis Pharma A/S (ASND), on Friday, announced that its supplemental Biologics License Application seeking approval of Skytrofa in the proposed treatment of adults with growth hormone deficiency has been accepted for review by the FDA.
The U.S. regulatory agency's decision on the expanded label is expected on July 27, 2025.
Adult growth hormone deficiency is a condition with symptoms like central obesity, metabolic issues, low bone density, changes in cholesterol levels, and increased heart disease risk.
In a phase III trial, dubbed foresiGHt, adults with GHD treated with Skytrofa, showed a statistically significant reduction in trunk fat and an increase in total body lean mass at Week 38, compared to those receiving a placebo. Notably, the treatment was well tolerated, with no patients discontinuing due to adverse effects, further emphasizing its safety profile.
Skytrofa, a human growth hormone, was approved by the FDA for the treatment of pediatric growth hormone deficiency in 2021.
The product generated revenue of €138.5 million for the first nine months of 2024, a 21% year-over-year increase compared to €114.4 million during the same period of 2023.
For the full year 2024, Skytrofa is projected to generate revenue between €200 million and €220 million. Skytrofa revenue totaled €179 million in 2023.
ASND closed Thursday's trading at $130.64, down 2.71%. In premarket trading today, the stock is down 1.26% at $129.00.
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