FDA Approvals: Briviact, Ibrance – Drug and Device Digest

FDA Brief: Week of Feb 15, 2016

FDA approved


BRIVIACT® (brivaracetam) tablets

UCB, Inc. Smyrna, Georgia

Indication : Add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

Unmet Need:

  • Approximately 5.1 million people in the United States have a history of epilepsy and approximately 2.9 million people in the United States have active epilepsy
  • Brain disorder that causes people to have recurring seizures
  • Need for new treatment option

Reg Pathway: NDA, standard review

Mechanism of Action: Binding to the ubiquitous synaptic vesicle glycoprotein 2A


  • 3 randomized, double-blind, fixed-dose, multi-center studies (n=1,550); 8-week baseline period followed by a 12-week treatment period, patients with uncontrolled partial onset seizures despite concomitant antepileptic therapy; Briviact vs Placebo
  • Effective in reducing the frequency of seizures.with Briviact vs placebo


  • Serious risks: Suicide thoughts / attempts,  depression, aggression, panic attacks, allergic reaction
  • Must be dispensed with Medication Guide
  • Most common side effects: Drowsiness, dizziness, fatigue, nausea and vomiting


palbo structure

IBRANCE® (palbociclib) capsules

Pfizer, Inc., NY

Indication: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:

  • letrozole as initial endocrine based therapy in postmenopausal women, or
  • fulvestrant in women with disease progression following endocrine therapy.

Reg Pathway:  

  • Accelerated approval in 2015 for combination treatment with letrozole for the treatment of HR-positive, HER2-negative advanced breast cancer as initial endocrine based therapy in postmenopausal women
  • This approval based on study showing profression free survival (PFS); Prior Approval sNDA, , Priority Review, Breakthrough designation


  • Single international, randomized, double-blind, parallel group, multicenter study (n=521); IBRANCE plus fulvestrant vs. placebo plus fulvestrant (n=521;  women with HR-positive, HER2-negative advanced breast cancer
  • Major efficacy outcome: Investigator-assessed PFS evaluated according to RECIST 1.1: 41.8% vs 65.5% , p p<0.0001
  • Median PFS was 9.5 versus 4.6 months



  • Most common adverse reactions: Neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, thrombocytopenia, constipation, vomiting, alopecia, rash, decreased appetite, and pyrexia


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