FDAsafety guidance83% confidence
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to pridopidine.
Regulatory Analysis
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
Supporting Context
- Therapeutic area
- Neurology · ALS
- Sub-indication
- General
Related signal: Pridopidine Phase 3 Trial Initiated for ALS Efficacy and Safety Evaluation
Source
FDA document
View source