FDA BRIEF: Week of February 27, 2017

FDA approved


xermelo
lexicon

XERMELO (telotristat ethyl) tablets, for oral use

Lexicon Pharmaceuticals, Woodlands, TX, USA

INDICATION: Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy

UNMET NEED:

  • Carcinoid syndrome seen with carcinoid tumors – rare, slow-growing
  • Tumors release excess serotonin, resulting in diarrhea leading to weight loss, malnutrition, dehydration, electrolyte imbalance
  • Need for another treatment option

REG PATHWAY:

  • NDA : Fast Track Designation, Priority Review, Orphan Drug Designation
  • Post-Marketing Requirements: 2-year rat carcinogenicity study, In-vitro interaction studies, hepatic impairment study

MECHANISM OF ACTION: Active metabolite, telotristat, inhibits tryptophan hydroxylase, mediator of serotonin biosynthesis

EFFICACY:

  • 12-week double-blind, placebo-controlled, randomized, multicenter trial, patients with metastatic neuroendocrine tumor and carcinoid syndrome diarrhea (n=90), XERMELO vs placebo
  • Primary efficacy endpoint: Change from baseline in daily bowel movements over 12 weeks
  • 33%  Xermelo patients vs. 4% placebo patients  with reduction of at lest 2 bowel movements

SAFETY:

  • Most common side effects: Nausea, headache, increased levels of the liver enzyme gamma-glutamyl transferase, depression, accumulation of fluid causing swelling (peripheral edema), flatulence, decreased appetite and feve
  • May cause constipation

LABEL


Image result for PhenoTest BC Kit
Accelerate

PHENOTEST BC Kit and Pheno System

Accelerate Diagnostics Inc., Tucson, AZ, USA

INDICATION FOR USE:

Multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno system.

The Accelerate PhenoTest BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms.

The Accelerate PhenoTest BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.

UNMET NEED:

  • First test to identify organisms causing bloodstream infections and identify antibiotics likely to respond (antibiotic sensitivity)
  • Reduces time taken to provide information,  expedite antibiotic treatment

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 866.1650
  • Regulation Name: A cellular analysis system for multiplexed antimicrobial susceptibility testing
  • Regulatory Classification: Class II
  • Product Code: PRH, NSU, PEO, PAM, PEN, LON

GENERIC DEVICE DESCRIPTION:

  •  Multiplex qualitative and/or quantitative in vitro device intended for the identification and determination of the antimicrobial susceptibility results of organisms detected in samples from patients with suspected microbial infections
  • Intended to aid in the determination of antimicrobial susceptibility or resistance when used in conjunction with other laboratory findings

IDENTIFIED RISKS AND MITIGATIONS:

  • False positive /False negative results, failure to perform appropriate AST testing, Organism determined to be resistant when susceptible, Organism determined to be susceptible when resistant: General controls and special controls
  • Errors in Interpretation: General controls and special controls
  • Failure to correctly operate the test system: General controls and special controls
  • Special Controls: Premarket notification submission requirements, labeling, results interpretation, principles of operation

CLASSIFICATION ORDER


 

Image result for odactra
google

ODACTRA™ House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use

Merck, Whitehouse, Station, NJ, USA

INDICATION: Allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age.

UNMET NEED:

  • House dust mite allergies commonly found in house dust;  found in bedding, upholstered furniture and carpeting
  • Cough, runny nose, nasal itching, nasal congestion, sneezing, itchy and watery eyes
  • Can negatively impact quality of life
  • Alternative treatment to allergy shots to help address symptoms

REG PATHWAY: BLA

MECHANISM OF ACTION:  Contain house dust mite allergen extract from Dermatophagoides farinae and Dermatophagoides pteronyssinus;  precise mechanisms of action of allergen immunotherapy have not been fully established

EFFICACY:

  • 2  double-blind, placebo-controlled, randomized clinical field efficacy studies  and one environmental exposure chamber (EEC) study, n = 2,500, ODATRA vs. placebo
  • Primary Endpoint: Difference in  average Total Combined Rhinitis Score ( TCRS) during last 8 weeks of treatment; other endpoints average rhinitis daily symptom scores(DSS) and rhinitis daily medication scores (DMS)
  • 16 to 18 %  reduction in symptoms and need for additional medications vs, placebo

SAFETY:

  • Most commonly reported adverse reactions: Nausea, itching in the ears and mouth, and swelling of the lips and tongue
  • Boxed warning: Severe  allergic reactions

LABEL


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levita magnetics

LEVITA Magnetic Surgical System

Levita Magnetics International Corp, San Mateo, CA, USA

INDICATION FOR USE: Designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 878.4815
  • Regulation Name: Magnetic Surgical Instrument System
  • Regulatory Classification: Class II
  • Product Code: PNL

GENERIC DEVICE DESCRIPTION:

Prescription device used in laparoscopic surgical procedures consisting of several components, such as surgical instruments, and a magnetic controller

Magnetic controller is provided separately from the surgical instrument and is used outside the patient

External magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize or manipulate soft tissue and organs.

RISKS AND MITIGATIONS:

  • Tissue Damage: In vivo Performance Testing,Human Factors Testing and Analysis, Training, Labeling
  • Need for Extended or Additional Surgery:In vivo Performance Testing, Non-clinical Performance Testing,Human Factors Testing and Analysis, Training, Labeling
  • Abdominal Wall Injury: In vivo Performance Testing, Human Factors Testing and Analysis, Labeling
  • Electromagnetic Field Incompatibility or Interference: Non-clinical Performance Testing, Human Factors Testing and Analysis, Training, Labeling
  • Adverse Tissue Reaction: Biocompatibility testing
  • Infection: Sterilization Validation, Reprocessing Validation, Shelf Life Validation, Labeling

CLASSIFICATION ORDER


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