Omeros (OMER) FDA Announcement summary

Introduction and purpose

• YARTEMLEA received FDA approval on December 23, 2025, as the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children aged two and older.

• The approval addresses a significant unmet need for a life-threatening complication in stem cell transplant recipients, previously managed only with supportive care.

Details of approval or decision

• YARTEMLEA is approved for all TA-TMA patients, both standard and high risk, including adults and children aged two and older, with no box warning, REMS, or vaccination requirement.

• Approval was based on a 28-patient pivotal trial and a 221-patient expanded access program.

• Dedicated billing and reimbursement codes have been established, and a U.S. product launch is planned for January 2026.

• A marketing authorization application is under review by the European Medicines Agency, with a decision expected mid-2026.

Impact on industry and stakeholders

• The launch is expected to shift the standard of care for TA-TMA, especially in pediatric patients, with early adoption focused on high-volume transplant centers.

• A new ICD-10 code and two CPT codes have been established, supporting reimbursement and limiting off-label therapy use.

• Providers and patients will have access to the YARTEMLEAssist™ support program in Q1 2026.

• The ex-U.S. opportunity is substantial, with a pending EMA application and partnership evaluations underway.