FDA BRIEF: Week of June 27, 2016

FDA approved

EPCLUSA (sofosbuvir and velpatasvir) tablet

Gilead Sciences, Inc., CA, USA

epclusa.jpg

INDICATION: Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection : (i) without cirrhosis or with compensated cirrhosis  (ii) with decompensated cirrhosis for use in combination with ribavirin

UNMET NEED: 

  • ~75% Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6
  • ~ 75 to 85% cases become chronic
  • Need for management and treatment option for a wider scope of  chronic HCV

REG PATHWAY: NDA, Priority Review

MECHANISM OF ACTION:  Fixed-dose combination of sofosbuvir and velpatasvir which are direct-acting antiviral agents against hepatitis C virus

EFFICACY:

  • Several studies

astral.JPG

  • Serum HCV RNA values measured using COBAS AmpliPrep/COBAS Taqman HCV test
  • Primary Endpoint: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment
  • Relapse: HCV RNA greater than or equal to LLOQ during the post-treatment period
  • On-treatment virologic failure: Breakthrough, rebound, or non-response
  • >90% patients receiving Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured

SAFETY:

  • Warning- Serious slowing of heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention
  • Most common side effects of Epclusa include headache and fatigue

LABEL


RAINDROP NEAR VISION INLAY

Revision Optics, Inc. of Lake Forest, CA, USA

INDICATION FOR USE:  Intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of (mrse) +1. 00 diopters (d) to -0. 50 d with less than or equal to 0. 75 d of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1. 50 d to +2. 50 d of reading add.

UNMET NEED:

  • Presbyopia is loss of ability to change focusing power of eye
  • Bifocals, reading glasses common correction method
  • Corneal inlay surgery elective option
  • Need for new option for surgical, outpatient treatment of presbyopia

REG PATHWAY: PMA, Product Code LQE

DEVICE DESCRIPTION:

  • Made of soft, biocompatible hydrogel; bioengineered to facilitate the transport of nutrients and fluid to the eye
  • Corneal inlay that creates a prolate-shaped cornea, and easily placed under a femtosecond laser flap of non-dominate eye; resembles a tiny water droplet.
  • Inlay provides steeper surface to help eye focus on near objects or print
  • By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.

EFFECTIVENESS:

  • Clinical trial , n=373
  • 92%  with 20/40 vision or better at near distances with the inlay-implanted eye 2 years post implantation.

SAFETY:

  • May cause or worsen problems with glare, halos, foreign body sensation and pain
  • Risks: Infection, inflammation, dry eye,  retinal detachment, decrease in distance vision, corneal complications, epithelial ingrowth

Patient Information Brochure


 

XPERT CARBA-R ASSAY

Cepheid, Sunnyvale, CA, USA

INDICATION FOR USE: Intended as an aid in infection control to detect and differentiate the most prevalent carbapenemase gene families in isolates expressing resistance and can be used in conjunction with other clinical and laboratory findings. Although the Xpert Carba-R Assay tests for the most prevalent carbapenemase genes associated with resistance to carbapenem antibiotics, it does not detect the bacteria, carbapenemase activity or other possible non-enzymatic causes of carbapenem resistance. The Xpert Carba-R Assay tests only for genetic material.

UNMET NEED:

  • Carbapenem antibiotics are widely used in hospitals to treat severe infections –  resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae (CRE)
  • Current methods to identify CRE colonization are bacterial culture methods and susceptibility testing that may take up to four days
  • Need for  rapid test using specimen taken directly from patient – quick identification

REG PATHWAY: 510(K), Class II, Code: POK

DEVICE DESCRIPTION:

  • Differentiates between KPC, NDM, VIM, IMP, and OXA-48 gene families, representing more than 90 different genes responsible for carbapenemase production
  • LIS connectivity enabling immediate implementation of infection control measures
  • Detection in  48 minutes.

EFFECTIVENESS:

  • Study using rectal swabs , n=755, patients in hospitals or long-term care facilities
  • Second study using rectal swabs, n=432, artificially prepared with specific concentrations of bacteria containing the genes detected by the test
  • Compared results from Xpert Carba-R Assay vs reference cultures and PCR sequencing
  • Similar performance between the Xpert Carba-R Assay and culture method.

SAFETY:

  • Does not detect all types of carbapenemase genes
  • Labs continue to perform standard bacterial culture in conjunction with  Assay

 

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