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FDA Medication Tracker

← All approvals · Rare & genetic · 2025

Kygevvi (doxecitine and doxribtimine)

The FDA approved Kygevvi (doxecitine and doxribtimine) on November 3, 2025 to treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger.
Brand name
Kygevvi
Generic name
doxecitine and doxribtimine
FDA approval date
November 3, 2025
Approved use (FDA wording)
To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger
Company
Ucb Inc.
Application
NDA219792
Dosage form / route
FOR SOLUTION · ORAL
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. KYGEVVI is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.