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
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
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
Image credits: Gilead, Janssen, NorthStar Medical