FDA Approvals: VEMLIDY, SELZENTRY pediatrics, ReEBOV Antigen Rapid Test, OPDIVO for SCCHN – Drug and Device Digest

FDA BRIEF: Week of Nov 7, 2016

FDA approved

VEMLIDY (tenofovir alafenamide) tablets

Gilead Sciences, Foster City, CA, USA

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INDICATION:  Treatment of chronic hepatitis B virus infection in adults with compensated liver disease


  • Chronic hepatitis B is a life-threatening illness
  • Affects up to 2.2 million people in the US

REG PATHWAY: SNDA (also marketed as Descovy)

MECHANISM OF ACTION: nucleoside analog reverse transcriptase inhibitor, inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination.


  • 2 randomized, double-blind, active-controlled studies,  48-week data, N=425 and N=873, patients  not allowed to receive other nucleosides, nucleotides, or interferon
  • VEMLIDY vs Tenofovir Disoproxil Fumarate (Viread)
  • Primary Endpoint: Proportion of subjects with plasma HBV DNA levels below 29 IU/mL at Week 48.
  • Additional endpoints:  Proportion of subjects with ALT normalization, HBsAg loss and seroconversion, and HBeAg loss and seroconversion
  • Noninferior to Viread


  • Boxed Warning: Risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B
  • Commonly reported adverse events: Headache, abdominal pain, fatigue, cough, nausea and back pain


SELZENTRY (maraviroc)

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INDICATION:  SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5 tropic human immunodeficiency virus type 1 (HIV 1) infection in patients 2 years of age and older weighing at least 10 kg.

FORMULATIONS:  20 mg/mL oral solution,  25 mg and 75 mg tablets
  • Open-label, multicenter trial,  2-<18 years old, infected with only CCR5 tropic HIV 1; dosing based on body sruface area and concomitant  potent CYP3A inhibitors and/or inducers.
  • At 48 weeks, 48% achieved plasma HIV-1 RNA less than 48 copies per mL; 65% achieved plasma HIV-1 RNA less than 400 copies per mL
  • Mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells per mm3 (5%).
  • Safety profile through 96 weeks was similar to that for adults

ReEBOV™ Antigen Rapid Test for Ebola Zaire Virus
Corgenix Inc, Broomfield CO, USA
Zalgen Labs, Germantown, MD
INTENDED USE: Intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus.
REG PATHWAY:  Emergency Use Authorization
  • Point-of-care test – self-contained, disposable dipstick-format lateral flow test that includes an internal process Control Lin
  • Ebola Zaire virus antigen, VP40 protein, present in the specimen, to bind nanoparticles labeled with antigen specific antibodies
  • . As the specimen and nanoparticles flow across the device membrane, immobilized Ebola Zaire virus antigenspecific antibody absorbs the nanoparticle immune- to generate chromogenic signal


OPDIVO (nivolumab) Injection
Bristol-Myers Squibb, Princeton, NJ, USA
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SUPPLEMENTARY INDICATION:  Treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy
  • International, multi-center, open-label, randomized trial  (n=240), OPDIVO vs  Investigator’s Choice of chemotherapy, patients with recurrent or metastatic SCCHN with disease progression
  • Primary Endpoint: Overall Survival (OS)
  • Statistically significant and clinically meaningful improvement in OS : Hazard Ratio 0.7 [95% CI: 0.52, 0.92]; p=0.0101
  • Estimated median OS: 7.5 mo, vs 5.1 mo.
  • Serious adverse reactions occurred:  Pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
  • Most common adverse reactions: Cough and dyspnea

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