FDA BRIEF: Week of October 3, 2016


FDA approved


ILARIS (canakinumab) injection

Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Image result for ilaris

INDICATIONS:

  • Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.
  • Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ILARIS is indicated for the treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
  • Familial Mediterranean Fever (FMF) ILARIS is indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients.

UNMET NEED:

  • 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.

REG PATHWAY:

Supplemental BLA. Previously approved for another periodic fever syndrome Cryopyrin-Associated Periodic Syndromes (CAPS) and for active systemic juvenile idiopathic arthritis.

EFFICACY:

  • 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

SAFETY:

  • Most common adverse reactions: Injection site reactions, cold susceptibility
  • Serious side effects: Risk of serious infections

LABEL


 

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EPIC ClearViewTM

EPIC Research & Diagnostics, Scottsdale, AZ , USA

Image result for EPIC ClearView

CLASSIFICATION: I

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.

IDENTIFIED RISKS:

  • 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)

FEDERAL REGISTER NOTICE


 

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