Home / Business and Economy / EMA Rejects Omeros' Rare Disease Drug Yartemlea
EMA Rejects Omeros' Rare Disease Drug Yartemlea
27 Jun
Summary
- European regulators issued an unfavorable recommendation for Yartemlea.
- Omeros' therapy treats a rare complication after stem cell transplants.
- The company has 15 days to request a re-examination of the opinion.
Omeros Corporation's shares experienced a significant decline following an unfavorable recommendation from European medical regulators regarding its therapy, Yartemlea. This decision impedes the drug's commercialization efforts in the European region.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Narsoplimab, marketed as Yartemlea. The CHMP found that the submitted study data lacked sufficient evidence to demonstrate Yartemlea's effectiveness, citing issues with study design and comparator treatments.
The regulator also highlighted concerns about changes made during the study, effectiveness measurements, and dosage selection. Insufficient data was provided for the proposed dosage in children. Omeros has been granted a 15-day window to request a re-examination of this opinion. Yartemlea is approved by the FDA in the United States for treating transplant-associated thrombotic microangiopathy in adults and children aged two and older.
