FDA Approvals/Final Orders: ADLYXIN, VIEKIRA XR, CYPASS, Iontophoresis Devices – Drug and Device Digest

FDA BRIEF: Week of July 29, 2016

FDA approved

ADLYXIN (lixisenatide) injection

Sanofi Aventis, Bridgewater, NJ, USA

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INDICATION: Adjunct to diet and exercise for the treatment of adults with type 2 diabetes.


  • > 29 million , >90% diabetes cases in US
  • Can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.
  • Need to add to available treatment options to control blood sugar levels

REG PATHWAY: Standard review. Post-marketing studies required – Pediatric, Immunogenicity.

MECHANISM OF ACTION: Glucagon-like peptide-1 receptor agonist (GLP-1 RA). GLP-1  suppresses glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.


  • GetGoal clinical program:  13 clinical trials,  5,400 patients with type 2 diabetes
    • Standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin.
    • Primary efficacy endpoint of HbA1c reduction – Achieved
  • Cardiovascular Outcomes Trial: > 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease

    • Adlyxin vs. placebo

    • No increase the risk of cardiovascular adverse events


  • Severe hypersensitivity reactions, including anaphylaxis
  • Most common side effects: Nausea, vomiting, headache, diarrhea and dizziness.

 VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) tablets



INDICATION:  Treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A).

NEW FORMULATION: Extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)

REG PATHWAY: Approval based on comparability of bioavailability for each of the components in VIEKIRA XR compared to that of the previously approved formulations in VIEKIRA Pak.


  • Components  studied in 7 Phase 3 clinical trials, n=1076
  • 95-100%  achieved SVR12, hepatitis C virus is not detectable in the blood three months after treatment ends



CYPASS System (Model 241-S)

Alcon Laboratories, Inc., Fort Worth, TX, USA

Image of the device. The Micro-Stent illustrates its 6.35mm length, three retention rings, proximal collar, and lumen. The applier (model 241-S) illustrates its front button (retracts guidewire), guidewire tube, guidewire, and rear button (extends guidewire).

INDICATION FOR USE: Minimally invasive glaucoma surgical device (MIGS) approved for use in combination with cataract surgery. ThE device helps to reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).



  • Small stent (CyPass Micro-Stent) contained within a loading device, and a stent delivery tool (CyPass® Applier).
  • Designed for placement in the angle of the eye, with the proximal end extending into the anterior chamber (AC), and the distal end residing in the supraciliary space
  • Allows outflow of fluid from the AC through the distal end into the supraciliary and suprachoroidal spaces.



  • Clinical trail in patients diagnosed with POAG (n=505)
  • Iimplanted with the CyPass® (n=74) vs. cataract surgery alone (n= 131 )
  • Primary Endpoint: % patients with 20%reduction in mean diurnal IOP  for 24 months after implantation.
  • Significant lowering of their IOP: 72.5 % vs. 58%; maintined in 2 year followup


  • Most serious AEs: Hypotony maculopathy, peripheral anterior choroidal effusion, intraocular lens (IOL) subluxation and corneal compromise
  • Most common safety concerns: Bleeding, inflammation, and damage to angle tissue (i.e., iridodialysis, larger than expected cyclodialysis cleft, ciliary body edema)
  • No reports: Loss of light perception, endophthalmitis, suprachoroidal hemmorrhage, diplopia, wound leak, flat anterior chamber, or bleb complications



Final Order:

  • Class II (special controls)
  • reclassify iontophoresis devices intended for any other purpose
  • Not covered: Devices intended to deliver  specific drugs
  • Required Performance Testing and Labeling



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