CMS TransmittalRheumatology

FDA Approval: EXDENSUR (DEPEMOKIMAB) — Type 1 - New Molecular Entity

FDA-BLA761458

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA761458
Published
June 13, 2026
Effective date
December 16, 2025
MAC region
National

Summary

This newly approved drug, EXDENSUR (Depemokimab), has a confirmed route of administration as subcutaneous injection, allowing billing teams to categorize it under Part B. As it aligns with injectable

New injectable drug approved; watch for J-code updates.

Affected specialty

Rheumatology alerts →

Source document

https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761458Orig1s000lbl.pdf

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