FDA BRIEF: Week of November 21, 2016

FDA approved


DARZALEX (daratumumab) injection

Janssen Biotech of Horsham, PA, USA

Image result for darzalex

INDICATION: In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

UNMET NEED:

  • 26,850 new cases of multiple myeloma and 11,240 related deaths in US in 2016
  • Blood cancer resulting in weakened immune system, bone or kidney problems
  • Need for tretament options for patients resistant to other therapies

REG PATHWAY: NDA, Breakthrough Designation, Priority Review, Orphan Drug Designation, Accelerated Approval program

  • Accelerated approval in 11/2015 for multiple myeloma monotherapy

MECHANISM OF ACTION: Binds to CD38 and inhibits CD38 expressing tumor cell growth by inducing apoptosis

EFFICACY:

  • 2 randomized, open-label trials (n=569, 498)  DARZALEX  added to standard therapies
  • Endpoint: Progression free survival (PFS) based on International Myeloma Working Group (IMWG) criteria
  • 61-63% reduction in risk of disease progression or death for patients treated with DARZALEX
  • Complete/partial reduction tumor burden: 29% – 36%, avg duration:  7.4 months
SAFETY:
  • Warnings and Precautions: Neutropenia and thrombocytopenia
  • Most frequently reported adverse reactions : Infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough and dyspnea. The most frequently reported adverse reactions (greater than or equal to 20%) in MMY3004 were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory ions of the DARZALEX label.

LABEL


XULTOPHY  (insulin degludec and liraglutide injection), for subcutaneous use 

Novo Nordisk, Bagsvaerd, Denmark

Image result for xultophy

INDICATION:  combination of insulin degludec and liraglutide; indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).

Limitations of Use: Not for  first-line therapy , not studied in patients with pancreatitis, not for use  with any other product containing liraglutide/GLP-1 receptor agonist,  not for patients with type 1 diabetes mellitus/ diabetic ketoacidosis, not studied in combination with prandial insulin.

REG PATHWAY: NDA with REMS of Communication Plan

EFFICACY:

  • 3 randomized, parallel and active-controlled, n=1393, 26 weeks duration; subjects converting from liraglutide, from any basal insulin, from insulin glargine
  • Endpoint: Reduction in HbA1c from baseline
  • 1.31% for XULTOPHY vs. 0.36% for liraglutide
  • 1.94% for XULTOPHY vs. 1.05% for insulin degludec
  • 1.67% for XULTOPHY vs. 1.16% for insulin glargine

SAFETY:

  • Boxed Warning: Risk of Thyroid Cell tumors
  • Adverse Reactions: Pancreatitis, Hypoglycemia, Acute Kidney Injury, Hypersensitivity and Allergic Reactions, Hypokalemia

LABEL


SOLIQUA  (insulin glargine and lixisenatide injection), for subcutaneous use

Sanofi-Aventis U.S. LLC; Bridgewater, NJImage result for soliqua

INDICATION: Combination of insulin glargine and lixisenatide; indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide.

Limitations of Use: Not studied in patients with pancreatitis, not for use in combination with any other product containing lixisenatide/GLP-1 receptor agonist, for use in patients with type 1 diabetes mellitus/ diabetic ketoacidosis, not studied in patients with gastroparesis, not studied in combination with prandial insulin.

REG PATHWAY: NDA with Post Marketing Requirements

EFFICACY:

  • Randomized, 30-week, activecontrolled, open-label, 2-treatment arm, parallel-group, multicenter study, n=736, SOLIQUA vs. insulin glargine, 30 weeks
  • Endpoint:  reduction in HbA1c from baseline
  •  -1.1% for SOLIQUA vs. -0.6% for insulin glargine

SAFETY: Anaphylaxis and Serious Hypersensitivity Reactions, Pancreatitis, Hypoglycemia, Acute Kidney Injury, Hypokalemia

LABEL


ABBOTT  RealTime ZIKA assay

Abbott Molecular Inc, Des Plaines, IL, USA

Image result for Abbott RealTime Zika assay

INTENDED USE: In vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the qualitative detection of RNA from the Zika virus in serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under CLIA

REG PATHWAY: Emergency Use Authorization

DEVICE DESCRIPTION:

  • Abbott mSample Preparation System
  • Abbott RealTime ZIKA Amplification Reagent Kit
  • Abbott RealTime ZIKA Control Kit
  • Internal Control

BIOLOGICAL PRINCIPLES:

  • RT-PCR to generate amplified product from the RNA genome of the Zika virus in human serum, plasma, urine
  • Dual target assay
  • Zika unrelated RNA sequence introduced into each specimen, processed and amplified by RT-PCR – serves as internal control (IC)
  • RealTime ZIKA assay detects the Zika virus and IC through target-specific fluorescent-labeled oligonucleotide probe

Labeling


 

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