FDA to give speedy review of Menkes disease drug

7 January 2025

Sentynl Therapeutics, an American subsidiary of India's Zydus Lifesciences, has announced that the US regulator will consider for approval CUTX-101.

The therapy would be the first treatment for Menkes disease, a rare, fatal pediatric disorder caused by mutations in the copper transporter gene ATP7A.

The application has been granted Priority Review, with a target action date set for June 30, 2025.

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