FDA BRIEF: Week of December 5 and 12, 2016

FDA approved


MACI  (autologous cultured chondrocytes on porcine collagen membrane)

Vericel Corporation, Cambridge, MA, USA

Image result for Maci AND vericel

INDICATION: Repair of single or multiple symptomatic, full thickness cartilage defects of the knee with or without bone involvement in adults.

UNMET NEED:

  • Knee problems common in all ages
  • Knee cartilage defects due injury, straining, overuse, muscle weakness, general wear and tear
  • Tailored therapy required; need to additional treatment option

REG. PATHWAY: BLA

  • First approval for process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

DESCRIPTION:

  • Autologous cultured chondrocytes on porcine Type I/III collagen
  • Autologous chondrocytes propagated in cell culture and seeded on collagen
  • MACI implant contains at least 500,000 cells per cm 2 and does not contain any preservative

EFFICACY:

  •   2-year prospective, multicenter, randomized, open-label, parallel-group study, MACI vs. Microfracture Treatment., patients with symptomatic articular cartilage defects in the knee, n=144, 104 weeks
  • Co-primary efficacy endpoint:  Change in Knee injury and Osteoarthritis Outcome Score (KOOS) in two subscales: Pain and Function (Sports and Recreational Activities [SRA]), week 104
  • Statististically significant improvement in KOOS pain and function (SRA) p = 0.001

SAFETY: Most common side effects:  joint pain, common cold-like symptoms, headache and back pain.

LABEL


EUCRISA (crisaborole) ointment 

Anacor Pharmaceuticals (Pfizer), Palo Alto, CA, USA

Image result for crisaborole ointment image

 

INDICATION:  Topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

UNMET NEED:

  • Atopic dermatitis (Eczema) , a chronic inflammatory skin disease
  • Caused by combination of genetic, immune and environmental factors
  • Skin develops red, scaly and crusted bumps, itchy and  “weeping” clear fluid
  • Need to another treatment option

REG. PATHWAY: NDA

MECHANISM OF ACTION: Phosphodiesterase 4 (PDE-4) inhibitor; results in increased intracellular cyclic adenosine monophosphate (cAMP) levels; specific therapeutic mechanism(s)  not well defined

EFFICACY:

  • 2 multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials , n=1522, EUCRISA vs. vehicle, twice daily for 28 days
  • Primary efficacy endpoint: Proportion of subjects with ISGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline
  • Greater ‘success’ with EUCRISA
  • eucrisa.JPG

SAFETY:

  • Serious side effect: Hypersensitivity reactions
  • Most common side effect: Site pain, including burning or stinging

LABEL


 

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