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PLECONARIL

DIVISION OF ANTIVIRAL DRUG PRODUCTS’ ADVISORY COMMITTEE MARCH 19, 2002. PLECONARIL. Advisory Committee Issues. New chemical entity First drug in a class Novel mechanism of action Analytic issues Safety issues. Advisory Committee Issues. New chemical entity First drug in a class

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PLECONARIL

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  1. DIVISION OF ANTIVIRAL DRUG PRODUCTS’ ADVISORY COMMITTEE MARCH 19, 2002 PLECONARIL

  2. Advisory Committee Issues • New chemical entity • First drug in a class • Novel mechanism of action • Analytic issues • Safety issues

  3. Advisory Committee Issues • New chemical entity • First drug in a class • other treatments provide relief of individual symptoms • Novel mechanism of action • prevents viral attachment to susceptible cells and prevents uncoating of rhinoviruses and enteroviruses

  4. Advisory Committee Issues • Analytic issues • variable trial results in 043 and 044 • treatment effect ranged from 0.5-1.5 days • treatment effect depended on study population • smokers vs. non-smokers

  5. Advisory Committee Issues • Safety issues • CYP3A4 induction • Effect on oral contraceptives(OC) • breakthrough bleeding • potential for unintended pregnancy • Potential for other drug interactions • Palpitations/tachycardia

  6. Questions Posed to Advisory Committee • Efficacy • consider treatment effect across studies • results in subgroups • use within 24 hours of symptoms • empirical use without a diagnostic assay

  7. Questions Posed to Advisory Committee • Safety issues related to: • CYP3A4 induction • decreased efficacy of OC • breakthrough bleeding and unintended pregnancies • potential drug interactions • Palpitations/tachycardia

  8. Questions Posed to Advisory Committee • Given that the effectiveness standard for approval requires substantial evidence from adequate and well controlled trials that must be balanced with safety, what level of risk is acceptable?

  9. Advisory Committee Agenda • 8:30 a.m.Viropharma Presentation • 9:30 a.m.FDA Presentation • 10:30 a.m.Break • 10:45 a.m.Discussion • 12:00 p.m.Lunch • 1:00 p.m.Open Public Hearing • 2:00 p.m.Continue Discussion and Questions to the Committee • 5:00 p.m.Adjourn

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