FDA Brief, Weeks of October 5 and 12, 2015 – Drug and Device Digest

ARISTADA (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use

Indication: Treatment of schizophrenia

Unmet Need:

Reg Pathway : 505(b)(2). Application relied on investigations not conducted by or for the applicant and no right of reference

Efficacy:

• Leveraged efficacy data from approved oral aripiprazole, ABILIFY, Otsuka Pharmaceuticals
• Additional data  12-week, randomized, double-blind, placebo-controlled, fixed-dose study (n=622) using Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression Improvement Scale (CGI-I)
• Demonstration of statistically significantly better PANSS and CGI-I scores versus placebo

Safety:

• Boxed Warning (Class labeling): Increased risk of death with off-label

• Most common side effect  : Akathisia –  urge to move constantly

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   OPTUNE – Device (Class III)

  

Unmet Need:

• 23,000 Americans diagnosed with brain or other nervous system cancers in 2015; >15,000 will die from them
• 15 percent of all brain tumors -Glioblastoma Multiforme (GBM) – ages 45 to 70; highly resistant tumor, < 15 months survival
• Need for new treatment option to increase survival

Reg Pathway : Priority Review of PMA supplement

Indication: Expanded indication for newly-diagnosed  GBM in combination with chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, and radiation therapy and chemotherapy used together.

Effectiveness:

• A multinational, open-label, randomized Phase 3 trial (n=695) , Optune  + TMZ vs TMZ alone
• Superior Progression-free Survival and Overall Survival. – study stopped early based on interim analysis
• Survival : 19.4 months vs 16.6 months
•  2-year survival rate  : 48% vs 32% (p=0.0058)

Safety: Skin irritation

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FilmArray Meningitis/Encephalitis (ME) Panel

First cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections.   ME Panel uses CSF specimens from patients who have signs and/or symptoms of meningitis or encephalitis.

Unmet need: 

• Meningitis and encephalitis are inflammatory diseases of the brain and spinal cord; caused by bacterial, viral or yeast infections;
• Needs rapid treatment – otherwise can cause brain damage and can be fatal
• ME Panel :
  •  Simple: 2 minutes of hands-on time
    • Easy: No precise measuring or pipetting required
    • Fast: Turnaround time of about 1 hour
    • Comprehensive: 14 bacterial, viral, and fungal targets

Reg Pathway : De novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device.

Indication : Intended as aid in diagnosis of meningitis and encephalitis  when used in conjunction with other clinical and laboratory findings.

Clinical Performance:  Comparison of ME panel results vs other tests (including culture) demonstrated high level of agreement

 Zensor wearable monitor for patients outside the hospital, 510 K Cleareance

• Small, battery-powered device that clips on to an adhesive patch which also contains electrodes
• Collects data on respiration rate, three-lead ECG, heart rate, and motion
• Data sent via wifi to the cloud, allowing a clinician to access it on a smartphone, desktop computer, or tablet.

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 NFant Feeding solution , 510 K clearance

Safety: 

• Most common side effects : fatigue, musculoskeletal pain, decreased appetite, cough and constipation
• Serious  “immune-mediated side effects” on healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.