An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Vaccines, Blood & Biologics

KEBILIDI

STN: 125722
Proper Name: eladocagene exuparvovec-tneq
Tradename: KEBILIDI
Manufacturer: PTC Therapeutics
Indication:

For the treatment of adult and pediatric patients with aromatic L amino acid decarboxylase (AADC) deficiency.

Product Information

Package Insert - KEBILIDI
Demographic Subgroup Information – eladocagene exuparvovec-tneql - KEBILIDI
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

Top