FDAsafety guidance72% confidence
Drug Trials Snapshots: YARTEMLEA
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Boehringer Ingelheim.
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
- Pulmonology · Lung Fibrosis
- Sub-indication
- Immunology
Related signal: Boehringer Ingelheim's Nerandomilast Trial for Lung Fibrosis in Autoimmune Diseases