FDA BRIEF: Week of October 3, 2016
- New indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:
- Hereditary diseases characterized by fever and inflammation, severe muscle pain
- No previously approved therapies for TRAPS or HIDS/MKD.
Supplemental BLA. Previously approved for another periodic fever syndrome Cryopyrin-Associated Periodic Syndromes (CAPS) and for active systemic juvenile idiopathic arthritis.
- 4-Part study (TRAPS, HIDS/MKD, and FMF Study 1) consisting of three separate, disease cohorts (TRAPS, HIDS/MKD and FMF)
- n=185 patients, age: > 28 days, Ilaris vs Placebo
- Primary Endpoint: Complete Response (Resolution of Index Flare by Day 15 and Maintained Through Week 16)
- TRAPS: 45.5% vs. 8.3%), p= 0.005
- HIDS/MKD: 35.1% vs. 5.7%, p=0.002
- FMF:61.3% vs 6.3%, p <0.0001
- Most common adverse reactions: Injection site reactions, cold susceptibility
- Serious side effects: Risk of serious infections
EPIC Research & Diagnostics, Scottsdale, AZ , USA
CODE: 21 CFR 882.1561.
GENERIC NAME: Evoked photon image capture device – e.g. EPIC ClearView
INTENDED USE: Non-invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.
- Adverse tissue reaction, electromagnetic incompatibility, and electromagnetic malfunction (e.g., shock)
- Not safe for use except under the supervision of a practitioner licensed by law
- Prescription device and must satisfy prescription labeling requirements ( 21 CFR 801.109 Prescription devices)