FDAsafety guidance83% confidence
Drug Trials Snapshots: YARTEMLEA
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Novartis.
Regulatory Analysis
YARTEMLEA is a prescription drug that is MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
Supporting Context
- Therapeutic area
- Hematology · Immune Thrombocytopenia
- Sub-indication
- General
Related signal: Novartis initiates tolerability study of ianalumab with TPO-RA in ITP patients