FDA BRIEF: Week of June 26, 2017

FDA approved


Image result for bevyxxa logo

BEVYXXA (betrixaban) capsules

Portola Pharmaceuticals, Inc.

INDICATION:  For the prophylaxis of venous thromboembolism (VTE) in adult patients  hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for  VTE

REG. PATHWAY: NDA

  • Required Pediatric assessments

MECHANISM OF ACTION: Oral FXa inhibitor, selectively blocks active site of FXa, decreases thrombin generation

EFFICACY:

  • Single randomized, double-blind, multinational study, n=7,513, patients hospitalized for acute medical illness, moderate or severe immobility, additional VTE risk
    factors, extended duration BEVYXXA vs. short duration enoxaparin
  • Composite Efficacy Endpoint: Asymptomatic proximal Deep Vein Thrombosis (DVT), Symptomatic proximal or distal DVT, Non-fatal Pulmonary Embolism (PE), VTE-related death
  • Composite Outcome, n(%) : 165 (4.4) vs. 223 (6.0)

SAFETY:

  • Most common adverse reactions (≥5%): Related to bleeding (betrixaban vs enoxaparin)
    • at least one adverse reaction: 54% vs. 52%
    • serious adverse reactions: 18% vs. 17%
    •  incidence rate for all bleeding episodes: 2.4% vs. 1.2%
    • major bleeding episodes: 0.67% vs. 0.57%

LABEL


Related image

 CLEARLLAB REAGENTS (T1, T2, B1, B2, M)

Beckman Coulter, Inc.

INTENDED USE: Authorized test for use with flow cytometry to aid in the detection of  several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN)

ADDRESSING UNMET NEED:

  • First FDA authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas
  • For laboratories and health care professionals to have an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers
REG PATHWAY: De Novo
  • Regulation Number: 21 CFR 864.7010
  • Regulatory Classification: Class II
  • Product Code: PWD

EFFECTIVENESS:

  • Study designed to demonstrate the test’s performance, n=279 samples at 4 independent clinical sites
  • Study compared the test’s results to alternative detection methods
  • Results of test aligned with the study site’s final diagnosis 93.4% of time
  • Correctly detected cancer presence 84.2% of time
DESCRIPTION:
  • Device:  Flow Cytometric Test System For Hematopoietic Neoplasms
  • Definition:  Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer.These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-hodgkin’s lymphoma, myeloma, myelodysplastic syndrome (mds), and/or myeloproliferative neoplasms (mpn)

EMBOSPHERE MICROSPHERES

BioSphere Medical, S.A. (Merit Medical)

INDICATION FOR USE: embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and prostatic arteries for symptomatic benign prostatic hyperplasia (BPH)

REG PATHWAY: De Novo

  • Regulation Number: 21 CFR 876.5550
  • Regulation Name: Prostatic artery embolization device
  • Regulatory Classification: Class II
  • Product Code: NOY

GENERIC DEVICE TYPE: Intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH). This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications

IDENTIFIED RISKS/MITIGATIONS:

  • Adverse tissue reaction: Biocompatibility evaluation
  • Infection: Sterilization validation, Shelf-life validation, Non-clinical performance testing, Labeling
  • Non-target ischemia: Clinical data, Non-clinical performance testing, Labeling
  • Urinary retention: Labeling
  • Post-prostatic artery embolization syndrome (nausea, vomiting, regional pain, non-infectious fever, minor hematuria or hematochezia): Labeling

ORDER


Image credits: Portola, Beckman Coulter, Merit

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