Capture.JPG

BIKTARVY (bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF)) tablet

Gilead

INDICATION: Complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of
BIKTARVY.

MECHANISM OF ACTION: Fixed dose tablet of antiretroviral drugs:

  • bictegravir (BIC) : Integrase strand transfer inhibitor
  • emtricitabine (FTC): HIV nucleoside analog reverse transcriptase inhibitor
  • tenofovir alafenamide : Acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate

EFFICACY ans SAFETY:

  • 2 trials each in (a) adults with no antiretroviral treatment history and (b) virologically suppressed adults, n=2,415
  • Met primary objective of non-inferiority at 48 weeks across all four studies
  • No partients  failed Biktarvy with treatment-emergent virologic resistance
  • No patients discontinued Biktarvy due to renal adverse events, no cases of proximal renal tubulopathy or Fanconi syndrome
  • Most common adverse reactions: Diarrhea, nausea and headache.

REGULATORY PATHWAY: NDA

  • Required postmarketing studies in pediatrics

REIMBURSEMENT: 

  • Patient Assistance programs: Gilead’s U.S. Advancing Access® program
  • Working closely with the AIDS Drug Assistance Programs (ADAP) Crisis Task Force to provide discounts to state ADAPs

LABEL


Capture.JPG

ZYTIGA (abiraterone acetate) in combination with prednisone

Janssen

INDICATION:  For metastatic high-risk castration-sensitive prostate cancer (CSPC)

EFFICACY:

  • Placebo controlled international clinical trial, n=1,199 patients, placebo controlled
  • Patients in both arms received gonadotropin releasing hormone or had bilateral orchiectomy
  • Major efficacy endpoint: Overall Survival. Median OS not estimable in ZYTIGA arm vs. 34.7 months in placebo arm, p<0.0001
  • Median time-to-initiation of chemotherapy: Not reached in ZYTIGA arm vs. 38.9 in  placebo arm, p<0.0001

SAFETY:

  • Adverse reactions:  Hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough

REGULATORY PATHWAY: sNDA

  • Priority Review; approved more than a month ahead of due date
  • Postmarketing commitment: Overall survival analysis
  • Initial approval in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC)
  • Expanded indication in 2012 for patients with metastatic CRPC

REIMBURSEMENT:

  • 100% of Medicare Part D and Medicare Advantage plans coverage; quantity limits and prior authorization
  • Tier 5- Non-preferred brand-name drug

LABEL


Capture

RADIOGENIX System (technetium Tc-99m generator )

NorthStar Medical

INDICATION FOR USE: Technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc-99m injection. Sodium Pertechnetate Tc-99m injection is indicated for use in the preparation of FDA approved diagnostic radiopharmaceuticals

Sodium Pertechnetate Tc-99m injection is also indicated:

In Adults for:

  • Thyroid Imaging
  • Salivary Gland Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteralreflux
  • Nasolacrimal Drainage System Imaging (dacryoscintigraphy)

In Pediatric Patients for:

  • Thyroid Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteralreflux

ADDRESSING UNMET NEED: 

  • Broad collaboration across FDA, Nuclear Regulatory Commission (NRC) and  industry
  • Tc-99m plays vital role in nuclear imaging studies for wide range of uses, including cancer and cardiology
  • Used > 80 percent of routine medical imaging procedures
  • Stable supply chain is critical due to limited shelf life
  • Approval restores U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years

MECHANISM OF ACTION: Pertechnetate ion distributes in the body similarly to iodide ion, but is not organified. In contrast to the iodide ion, the pertechnetate is released unchanged from the thyroid gland.

EFFECTIVENESS AND SAFETY:

  • Did not require new clinical studies because it relied on safety and efficacy information and data from an already FDA-approved Tc-99m generator
  • Common side effects: Allergic reactions, including anaphylaxis

REGULATORY PATHWAY: NDA

  • Complete response to FDA’s November 4, 2013, action letter
  • Exempt from pediatric requirements
  • Postmarking requirements: Evaluation of fluid path bioburden and final product endotoxins and sterility

LABEL


 Image credits: Gilead, Janssen, NorthStar Medical

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s