Ascensis Pharma Says FDA Will Review Application for Adult Treatment of Growth Hormone Deficiency

Dow Jones2024-12-13

By Paul Ziobro

Ascendis Pharma said the Food & Drug Administration will review an application to expand the use of its drug to treat growth hormone deficiency to adults.

The Danish biopharma company on Thursday said the FDA accepted its supplemental biologics application in adult growth hormone deficiency for TransCon hGH, which is marketed as Skytrofa for pediatric patients.

"This marks another step towards achieving our objective to expand Skytrofa's label beyond pediatric GHD and expand its reach to address new groups of patients," Ascendis Chief Executive Jan Mikkelsen said.

The application is based on results from a trial that compared the efficacy and safety of weekly TransCon hGH with a weekly placebo and daily human growth hormone in adults with growth hormone deficiency.

Write to Paul Ziobro at paul.ziobro@wsj.com

(END) Dow Jones Newswires

December 12, 2024 17:21 ET (22:21 GMT)

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