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LYMErix  Lyme Disease Vaccine (Recombinant Osp A)

LYMErix  Lyme Disease Vaccine (Recombinant Osp A). Center for Biologics Evaluation and Research May 21, 2002. LYMErix . Voluntary withdrawal of sale Distribution discontinued February 2002 Announced February 2002 GSK cited poor sales. LYMErix . (Voluntary withdrawal of sale cont.)

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LYMErix  Lyme Disease Vaccine (Recombinant Osp A)

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  1. LYMErixLyme Disease Vaccine (Recombinant Osp A) Center for Biologics Evaluation and Research May 21, 2002

  2. LYMErix Voluntary withdrawal of sale • Distribution discontinued February 2002 • Announced February 2002 • GSK cited poor sales

  3. LYMErix (Voluntary withdrawal of sale cont.) • No further vaccinations recommended • Clinical trial vaccination ended • Dear Doctor / Investigator letters • Refund for returned vaccine

  4. Phase 4 Safety Study Overall goal - to detect rare, but significant adverse events associated w/ product use that may not be recognized in studies of sizes typical of pre-licensure studies

  5. LYMErixPhase 4 Design Originally Planned: • 25,000 adults,  1 dose LYMErix • 75,000 age- & sex-matched controls • 2-year accrual period • Harvard Pilgrim Health Care (HMO)

  6. LYMErixPhase 4 Methods • Events identified using ICD-9 codes • Ambulatory & in-patient claims data

  7. LYMErixPhase 4 Methods • Outcomes confirmed by blinded review • Record review by subspecialist • Established diagnostic criteria used where applicable • Incidence of predefined AEs in exposed cohort compared to incidence in unexposed cohort

  8. LYMErixPhase 4 Endpoints • Primary New onset inflammatory arthropathy • Other • Selected neurologic disorders: MS, GBS, acute disseminated encephalomyelitis, transverse myelitis, cranial neuritis, mononeuritis multiplex, myasthenia gravis, syringomyelia - Lyme disease - Rheumatoid arthritis - Allergic events - Hospitalization - Death

  9. LYMErixPhase 4 Update Low accrual rate • Additional HMO sites added in 2001 • Tufts (New England) • Health Partners (Upper Midwest) • Accrual period extended to 3 years (1999-2001)

  10. LYMErix Phase 4 Accrual

  11. LYMErix Phase 4 Accrual

  12. LYMErix Phase 4 Study 8th Q Report (01/21/02)

  13. LYMErix Follow Up • GSK will complete full safety follow up for: • All ongoing adult & pediatric clinical trials • Phase 4 post-marketing study • 4-year post-vaccination follow up • Final study report 2006 • FDA will continue to monitor IND & VAERS reports

  14. THE END

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