FDA BRIEF: Week of Nov. 28, 2016

FDA approved


JARDIANCE (empagliflozin) tablets

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

Image result for jardiance

NEW INDICATION: Reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease

UNMET NEED:

  • 70% higher cardiovascular deaths in diabetics
  • Need for treatment option to reduce deaths

REG PATHWAY:

  • sNDA
  • First approval in 2014 for improvement in  glycemic control in type 2 diabetes mellitus

EFFICACY:

  • Postmarketing study – part of post approval requirement
  • n=7000, patients with type 2 diabetes and cardiovascular disease, JARDIANCE vs placebo, followed for  3.1 years
  • Primary Endpoint: Major adverse cardiovascular event (MACE)
  • Significant reduction in the time to first occurrence of primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke
  • Significant reduction in the risk of cardiovascular death; no change in non-fatal myocardial infarction or non-fatal stroke

SAFETY:

  • Dehydration and hypotension, ketoacidosis, serious urinary tract infection, acute kidney injury and impairment in renal function, hypoglycemia,  vaginal yeast infections, genital mycotic infections, and increased cholesterol.

LABEL


BRAINPULSE 100

Jan Medical, Mountain View, CA, USA

INDICATION FOR USE:  For use on a patient’s head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle. The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.

REG PATHWAY: De Novo

  • Regulation Number: 21 CFR 882.1630
  • Regulation Name: Cranial Motion Measurement Device:  Prescription device; utilizes accelerometers to measure motion or acceleration of skull; not for diagnostic purposes.
  • Regulatory Classification: Class II
  • Product Code: POP

DEVICE DESCRIPTION:

  • 3 main components: a headset, data collector, and computer
  • Headset: Forehead photoplethysmograph (PPG) sensor (pulse rate), Sound Pressure Level (SPL) sensor (ambient environment noise), six accelerometers (skull acceleration at six selected locations)
  • Data collector: Converts analog signals to digital data stream via Ethernet cable to  computer
  • Computer: Software to initiate/end recordings, save data
  • Not capable of displaying recorded data

SAFETY & EFFECTIVENESS:

  • 6 clinical studies
  • 616 successful recordings evaluated from 273 patients across studies
  • Demonstration of correlation of measured skull motion to regular pulse related to cardiac cycle
  • No major variations in within-patient recordings
  • Discomfort (n=2) when wearing the headset – no other adverse events, complaints, device issues or malfunctions

CLASSIFICATION ORDER


 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s