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.
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
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
- 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
- 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)