Genzyme Corporation, a Sanofi company, and Gamida Cell Ltd. have received U.S. Food and Drug Administration approvals for separate supplemental Biologics License Applications (sBLAs), introducing labeling updates for Thymoglobulin® and Omisirge (omidubicel-onlv), respectively
Written By: Pharmacally Medical News Desk
The FDA has approved a supplemental application submitted by Genzyme Corporation, a Sanofi company, for Thymoglobulin® (anti-thymocyte globulin [rabbit]), alongside a separate labeling update for Omisirge (omidubicel-onlv), sponsored by Gamida Cell Ltd.
Thymoglobulin® Labeling Updates
Thymoglobulin® is a rabbit-derived polyclonal anti-thymocyte globulin used as an immunosuppressive therapy. It has been widely utilized in transplantation settings, particularly for the prophylaxis and treatment of acute rejection following kidney transplantation, where it works by depleting T-lymphocytes and modulating immune responses. Over time, the product has also been incorporated into various immunosuppressive protocols across both adult and pediatric patients.
Major Labeling Updates
Removal of Boxed Warning
One of the most notable updates is the removal of the boxed warning. This change reflects FDA’s reassessment of how risk information is best communicated within the labeling framework.
Clarification of Indications
Section 1 (Indications and Usage) now explicitly specifies use in both:
- Adult populations
- Pediatric populations
This update improves clarity for prescribers managing immunosuppressive therapy across age groups.
Updated Safety and Risk Information
Streamlined Warnings and Precautions
Section 5 (Warnings and Precautions) has been revised to present risk and mitigation information in a more structured and concise format. The intent is to enhance readability and clinical usability.
Expanded Postmarketing Experience
Section 6.2 (Postmarketing Experience) now includes additional adverse events:
- Anemia, including hemolytic anemia
- Thrombotic microangiopathy
- Hepatic failure
- Hyperbilirubinemia
These updates provide clinicians with a broader safety context derived from real-world use.
Pediatric Use Data
Section 8.4 (Pediatric Use) has been updated to clearly describe the supporting evidence for pediatric use. This is particularly relevant for transplant and immunosuppression settings where Thymoglobulin® is frequently utilized.
Patient-Focused Labeling
The FDA has also approved the draft content of the Patient Package Insert, reinforcing the importance of accessible safety information for patients and caregivers.
Omisirge Labeling Update
Omisirge (omidubicel-onlv) is a cell therapy indicated for use in patients requiring hematopoietic stem cell transplantation. The newly approved supplemental application introduces a targeted labeling revision focused on product handling instructions.
Removal of “Do Not Open Until Thaw” Instruction
The update removes the “do not open until thaw” instruction from:
- The Package Insert
- Cassette labeling
This revision reflects an update to product handling instructions and reduces potential ambiguity in clinical practice. The change does not alter thawing requirements but clarifies labeling language.
Regulatory and Compliance Considerations
The approval letters outline standard post-approval requirements, including submission of final labeling in Structured Product Labeling (SPL) format, adherence to promotional labeling regulations, and alignment of promotional claims with approved prescribing information. The FDA also reiterates that comparative or superiority claims must be supported by substantial evidence.
Why This Update Matters
While the Thymoglobulin® revisions focus on safety communication, risk clarity, and patient population specification, the Omisirge update addresses practical labeling instructions relevant to product preparation and handling.
Collectively, these approvals reflect FDA’s continued efforts to:
- Improve labeling clarity
- Enhance safety transparency
- Support real-world clinical use
- Reduce ambiguity in product instructions
Reference
Supplement Approval, Thymoglobulin, BL 103869/5738, https://www.fda.gov/media/191107/download?attachment
Supplement Approval, Omisirge, BL 125738/78, https://www.fda.gov/media/191086/download?attachment
Thymoglobulin, Updated Prescribing Information, https://www.fda.gov/media/74641/download
Omisirge, Updated Prescribing Information,
