Omeros Corporation received FDA approval for YARTEMLEA, the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
YARTEMLEA demonstrated high complete response rates and a strong survival benefit in clinical trials.
The approval marks a breakthrough in TA-TMA care, providing a new treatment option for patients.
First and Only Option
YARTEMLEA is the only approved therapy for TA-TMA in adults and children aged two and older.
High Complete Response Rates
Patients treated with YARTEMLEA achieved CR rates of 61% in pivotal trials and 68% in the Expanded Access Program.
Survival Benefit
100-day survival rates from TA-TMA diagnosis were 73% in pivotal trials and 74% in evaluable EAP patients.
Safety Profile
YARTEMLEA has no Boxed Warning or REMS requirements, with serious adverse reactions reported.
- YARTEMLEA's approval offers a potential paradigm shift in TA-TMA treatment, addressing an unmet medical need.
- The therapy's efficacy in improving survival rates and response rates highlights its significance in the field of hematopoietic stem cell transplantation.
The approval of YARTEMLEA represents a significant advancement in TA-TMA therapy, providing hope for patients with this severe complication. Omeros Corporation's groundbreaking achievement is poised to reshape the treatment landscape for this condition.