FDA News, Weeks of Oct 26 and Nov 2, 2015 – Drug and Device Digest


MINUTES : MDUFA IV Reauthorization Meeting : FDA and Industry

  • FDA’s response to Industry’s data request,
  • CDRH information systems for premarket reviews
  • Implementation of the Independent Assessment
  • Financial analysis.


  • Determine schedule for negotiation meetings in 2016
  • FDA to provide add’l information on 510(k) and de novo programs prior to next mtg
  • Next meeting is scheduled on November 18, 2015.


FDA approved


YERVOY (Ipilimumab) injection

Indication: Adjuvant treatment of cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Unmet Need: improvement in recurrence-free survival

Reg Pathway: Supplemental BLA, Standard Review


  • Randomized (1:1), double-blind, placebo-controlled trial (n=951), Yervoy vs Placebo
  • Primary Endpoint : Recurrence-free survival (RFS), 26 months vs 17 month, p<0.002


Grade 3-5 immune mediated adverse reactions : Enterocolitis, hepatitis, endocrinopathy, dermatitis, neuropathy
Most common adverse reactions: rash, pruritus, diarrhea, nausea, colitis, vomiting, weight loss, fatigue, pyrexia, headache, decreased appetite, and insomnia.


NUCALA (mepolizumab), injection, for subcutaneous use

Indication: Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype

Unmet Need:

  • Asthma is a chronic disease causing inflammation in the airways of the lungs
  • Severe attacks can be serious and even life-threatening
  • > 22 million people in U.S. have asthma
  • > 400,000 asthma-related hospitalizations each year

Reg Pathway: Standard, BLA

Mechanism of Action: Humanized IL-5 antagonist monoclonal antibody; IL-5 signaling inhibitor, reduces  production and survival of eosinophils; however, the mechanism of mepolizumab action in asthma has not been definitively established.


  • 1 dose-ranging and exacerbation trial (Trial 1) and 2 confirmatory trials (Trials 2 and 3, n=711), Nucala vs placebo
  • Primary Endpoint : Significantly fewer exacerbations  requiring hospitalization and/or emergency department visits
  • High responder rate with Nucala based on Asthma Control Questionnaire-5 (ACQ-5) and the St. Georges Respiratory Questionnaire (SGRQ)
  • Greater reductions in daily maintenance oral corticosteroid dose, while maintaining asthma control, with Nucala
  • However; no improvement  in lung function with Nucala


  • Most common side effects: Headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue)
  • Hypersensitivity reactions


GENVOYA (fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)

Indication : Treatment for HIV in  adults and children ages 12 years and older weighing at least 35 kilograms (77 pounds) who have never taken HIV therapy (treatment-naïve) and HIV-infected adults whose HIV-1 virus is currently suppressed

Unmet Need:

  • 1.2 million persons ages 13 years and older are living with HIV infection
  • 50,000 persons unaware of  infection
  • Fixed dose combination of effective, once daily complete regimen


  • 4 clinical trials (n=3,171)
  • Genvoya effective in reducing viral loads and comparable to the other treatment regimens.


  • Boxed Warning  Can cause a buildup of lactic acid in blood and severe liver problems
  • Serious side effects: New or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome)

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