Ascendis Pharma Gets Orphan Drug Exclusivity for Yuviwel

Dow Jones

Apr 07

By Elias Schisgall

Ascendis Pharma received orphan drug exclusivity from the Food and Drug Administration for Yuviwel, a treatment for a rare genetic disorder.

The Danish biopharmaceutical company also said Monday that Yuviwel, known generically as navepegritide, is now available commercially in the U.S.

The drug is used to treat achondroplasia, a genetic disorder that causes dwarfism. It was first designated an orphan drug by the FDA in 2019, and the new designation from the FDA gives Ascendis U.S. marketing exclusivity for the drug through February 2033.

"We're excited to see the FDA grant orphan drug exclusivity for Yuviwel, acknowledging it as a highly differentiated treatment option," Chief Executive Officer Jan Mikkelsen said.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

April 06, 2026 16:13 ET (20:13 GMT)

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It was first designated an orphan drug by the FDA in 2019, and the new designation from the FDA gives Ascendis U.S. marketing exclusivity for the drug through February 2033. \n\n\n  \"We're excited to see the FDA grant orphan drug exclusivity for Yuviwel, acknowledging it as a highly differentiated treatment option,\" Chief Executive Officer Jan Mikkelsen said. \n\n\n \n\n\n  Write to Elias Schisgall at elias.schisgall@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  April 06, 2026 16:13 ET (20:13 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":true,"need_login_tip":false,"code":"91000000","status":"200"}}}