Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMA
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Omeros' marketing authorization application for narsoplimab in TA-TMA, blocking approval in Europe for the time being. Omeros intends to request a re-examination of the opinion and will seek a review by an independent Ad Hoc Expert Group to challenge the decision.
Key figures
- Tma prevalence rate
- 56 percent
- Trial infection rate
- 36%
- Severe tma mortality rate
- 90 percent
- Annual allogeneic transplants eu us
- 30000
AI analysis
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