Image result for fluarix logoFLUARIX QUADRIVALENT (Influenza Vaccine) Suspension for Intramuscular Injection

GlaxoSmithKline

INDICATION: Active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Approved for use in persons aged 3 years and older

IMMUNOLOGICAL EVALUATION IN CHILDREN:

  • Randomized, double-blind, active-controlled, safety, immunogenicity, and noninferiority trial, FLUARIX QUADRIVALENT (n = 791) vs. comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 819 or TIV-2, 426 n = 801), age 3-17 years
  • Endpoint: % achieving seroconversion.  Non-Inferiority achieved

SAFETY:

  • Injection site adverse reactions:  pain, redness, swelling
  • Systemic adverse events: drowsiness, irritability, loss of appetite, fatigue, muscle aches, headache, arthralgia, gastrointestinal symptoms

REGULATORY PATHWAY: BLA

  • Initial approval in 2012
  • Extended to age range to include children 6 to 35 months of age

REIMBURSEMENT:  

  • Vaccine product codes as well as some common administration codes associated with immunization

LABEL


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LYNPARZA (olaparib) tablet

AstraZeneca Pharmaceuticals

SUPPLEMENTAL INDICATION: Indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic

ADDRESSING UNMET NEED:

  • Approximately 20-25% patients with hereditary breast cancers and 5-10%  have a BRCA mutation
  • First treatment for breast cancer with a certain inherited gBRCAm HER2-negative metastatic breast cancer
  • Patients selected for treatment based on an FDA-approved genetic test – BRACAnalysis CDx.

MECHANISM OF ACTION:  Poly (ADP-ribose) polymerase (PARP) inhibitor

EFFICACY:

  • Open-label study (n=302) patients with gBRCAm HER2-negative metastatic breast cancer, LYNPARZA vs. healthcare provider’s choice of chemotherapy. Tested with the BRACAnalysis CDX to confirm deleterious or suspected deleterious gBRCAm status
  • Major efficacy outcome measure: Progression Free Survival (PFS)  assessed by blinded independent central review using RECIST version 1.1
  • PFS Number of events: 163 (80%) vs. 71 (73%), p=0.0009

SAFETY:

  • Common side effects: Anemia), neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and inflammation and sores in the mouth
  • Severe side effects:  Myelodysplastic syndrome/acute myeloid leukemia, pneumonitis
  • Cause harm to a developing fetus and newborn baby

REGULATORY PATHWAY: sNDA

  • Priority Review
  • First approved in 2014 to treat certain patients with ovarian cancer

REIMBURSEMENT:

  • No Medicare coverage for previously approved indication (specialty product); high copay

LABEL


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GILOTRIF (afatinib) tablets

Boehringer Ingelheim Pharmaceutical

SUPPLEMENTAL INDICATION:  First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy have not been established in patients whose tumors have resistant EGFR mutations

MECHANISM OF ACTION: Covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling

EFFICACY:

  • In NSCLC patients harboring non-resistant EGFR mutations (S768I, L861Q, and/or G719X) other than exon 19 deletions or exon 21 L858R substitutions enrolled in one of three clinical trials – pooled analysis
  • Non-resistant EGFR mutations identified using either Sanger sequencing or by  therascreen EGFR RGQ PCR Kit.
  • Confirmed overall response rate: 66% .
  • Among the 21 responders, 52% had response duration of ≥12 months and 33% had response duration  ≥18 months

SAFETY:

  • Most common adverse reactions: Diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritis

REGULATORY PATHWAY: sNDA

  • Priority Review and Orphan Drug Designation
  • Initial approval in 2013 for treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations
  • This approval broadens the patient population

REIMBURSEMENT: 

  • 100% of Medicare Part D and Medicare Advantage plan coverage; Tier 5 (non-preferred brand-name drugs)
  • Restrictions: Quantity limits, Prior Authorization

LABEL


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REMOVE System

Ovesco Endoscopy AG

INDICATION FOR USE: 

The remOVE System consists of the DC Impulse and the DC Cutter Set.
The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract.
The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips.

GENERIC DEVICE TYPE: Endoscopic electrosurgical clip cutting system

Prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection.
The system includes instruments that are then used to remove the fragmented clips from the digestive tract.

RISKS AND MITIGATION MEASURES:

  • Unintended tissue damage (burns, perforations, bleeding):  Animal performance testing, Non-clinical performance testing, Electrical and thermal safety testing, Usability testing, Labeling
  • Electromagnetic interference / Electrical shock: Electromagnetic compatibility testing, Electrical safety testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • Infection: Sterilization validation, Shelf life testing, Labeling

REGULATORY PATHWAY: De Novo

  • Regulation Number: 21 CFR 876.4310
  • Regulation Name: Endoscopic electrosurgical clip cutting system
  • Regulatory Class: Class II
  • Product Code: QAG

REIMBURSEMENT: Pending

LABEL

CLASSIFICATION ORDER


Image credits: GSK, AstraZeneca, Boehringer Ingelheim, Ovesco

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