Dupixent Prescribing Information Changes: How Supplied Section Updates 2020-2024

By Rhizome Team

Dupixent (dupilumab) has undergone several updates to its FDA-approved prescribing information over the past four years, particularly in the "How Supplied" sections. These changes reflect new presentations, packaging configurations, and regulatory approvals for expanded indications.

Understanding the chronology of these changes is essential for regulatory professionals, healthcare providers, and manufacturers tracking the evolution of this important biologic medication. The "How Supplied" section updates often coincide with new device presentations, strength additions, or manufacturing changes.

This comprehensive analysis examines all documented changes to Dupixent's prescribing information from 2020-2024, with specific focus on how the "How Supplied" sections have evolved with new auto-injector presentations, pre-filled pen additions, and regulatory label updates.

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Prepare a list with dates for all changes to the FDA-approved prescribing information for Dupixent in the last 4 years including changes to the "How Supplied" sections.

Answer

Certainly! Here is a comprehensive, consolidated answer summarizing all changes to the FDA-approved prescribing information for Dupixent (dupilumab) in the last 4 years (mid-2020 to mid-2024), including changes to the "How Supplied" sections. Where answers conflict or differ in interpretation, this is noted and summarized.

Summary Table of Major Labeling Changes (2020–2024)

DateSupplement/Label RefNature of Change"How Supplied" Section Impacted?Notes/Citations
Dec 15, 2020sBLA 761055/S-031Approval of 200 mg (175 mg/mL) auto-injector (pre-filled pen)YesNew device presentation added to "How Supplied" 1824
May–Aug 2021sBLA 761055/S-031Label update: detailed "How Supplied" info for pre-filled pens and syringesYesNDCs, pack sizes, storage/handling updated 263031
Aug 26, 2021sBLA 761055/S-031Label and Labeling ReviewNot specifiedGeneral update, may include "How Supplied" 5
Feb 3, 2022sBLA 761055/S-040New indication: eosinophilic esophagitis (EoE)Likely (not explicit)Labeling updated for new indication 12127
Mar 15, 2022sBLA 761055/S-040Label and Labeling ReviewNot specified5
Apr 26, 2022sBLA 761055/S-040EoE indication, labeling updateNot specified10
May 2022sBLA 761055/S-040EoE indication, label updateNo major change2728
2023 (after Nov 14)sBLA 761055/S-050Instructions for Use updateNot specified12
Mar 2024sBLA 761055/S-055Label update: same "How Supplied" as prior yearsNo major change25
Mar 15, 2024sBLA 761055/S-066New indication: CRSwNP (chronic rhinosinusitis with nasal polyps)Not specified17
Jun 2024sBLA 761055/S-064New indication: COPD with eosinophilic phenotypeNot specified1120

Detailed Narrative Summary

1. December 2020 – Approval of New Auto-Injector Presentation

  • Change: FDA approved a new 200 mg (175 mg/mL) auto-injector (pre-filled pen) for Dupixent.
  • Impact: The "How Supplied" section was updated to include this new presentation, with details on dosage strength and packaging.
  • Citations: 1824

2. 2021 – Expanded Labeling for Presentations and Storage

  • Change: Label updated to include detailed "How Supplied/Storage and Handling" information, listing available pre-filled pens and syringes, pack sizes, NDCs, and storage instructions.
  • Impact: "How Supplied" section was explicitly updated.
  • Citations: 263031

3. 2021–2022 – New Indications and General Label Updates

  • Change: Several label and labeling reviews and new indications (e.g., eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps) were approved.
  • Impact: While these updates required changes to the prescribing information, it is not always explicitly stated if the "How Supplied" section was changed. However, new indications often result in clarifications or updates to this section.
  • Citations: 15101316172127

4. 2022–2024 – Continued Label Updates, No Major "How Supplied" Changes

  • Change: Label updates for new indications (e.g., EoE, COPD), Instructions for Use, and general label maintenance.
  • Impact: Based on available label versions from 2021, 2022, and 2024, the "How Supplied" section (Section 16) remained consistent in terms of dosage forms, strengths, packaging, and NDCs. No new strengths or packaging configurations were introduced after the 2021 updates.
  • Citations: 2526282931

Conflicting Interpretations & Gaps

  • Some sources suggest possible updates to the "How Supplied" section with each new indication, but no explicit evidence of new presentations or major changes after 2021 is found in the label text.
  • All sources agree that the major change to the "How Supplied" section in the last 4 years was the addition of the 200 mg auto-injector (pre-filled pen) in late 2020/early 2021.
  • Subsequent label updates (2022–2024) focused on new indications and minor updates, with the "How Supplied" section remaining stable.

Final List: All Changes to Prescribing Information (2020–2024)

  1. December 2020: Addition of 200 mg (175 mg/mL) auto-injector (pre-filled pen) to "How Supplied" 1824.
  2. 2021: Expanded and clarified "How Supplied" section with detailed pack sizes, NDCs, and storage/handling instructions for all presentations 263031.
  3. 2022–2024: Label updates for new indications (eosinophilic esophagitis, CRSwNP, COPD) and Instructions for Use; "How Supplied" section unchanged in terms of presentations and packaging 15101112131617202125272829.

References

  1. 1 FDA Submission Data, Feb 3, 2022
  2. 5 FDA Label and Labeling Reviews, 2021–2022
  3. 10 FDA Approval Letter, Apr 26, 2022 (EoE indication)
  4. 11 FDA Approval Letter, Jun 2024 (COPD indication)
  5. 12 FDA Approval Letter, 2023 (Instructions for Use update)
  6. 13 FDA Multidisciplinary Review, Dec 2021
  7. 16 FDA Approval Letter, Jul 9, 2021 (long-term safety data)
  8. 17 FDA Approval Letter, Mar 15, 2024 (CRSwNP indication)
  9. 18 FDA Approval Letter, Dec 21, 2020 / 2021 (100 mg syringe, asthma indication)
  10. 20 FDA-Approved Labeling, 2024
  11. 21 FDA Approval Letter, Feb 3, 2022 (EoE indication)
  12. 24 FDA Approval Letter, Dec 15, 2020 (200 mg pen)
  13. 25 FDA Label, Mar 2024
  14. 26 FDA Label, May 2021
  15. 27 FDA Approval Letter, May 2022 (EoE indication)
  16. 28 FDA Label, May 2022
  17. 29 FDA Label, 2024
  18. 30 FDA Label, 2021 (Description section)
  19. 31 FDA Label, 2021 ("How Supplied" section)

If more granular or minor changes are required, consult the full revision history on the FDA Drugs@FDA database.