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

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Presentation transcript:

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 ( )

10 LYMErix  Phase 4 Accrual VaccineesUnexposed Planned01/01/99 25,00075,000 3 rd Q Report12/15/ th Q Report01/21/ ,580

11 LYMErix  Phase 4 Accrual VaccineesUnexposed 8 th Q Report 01/21/02 Overall764321,580 HPHC Tufts Health Partners

12 LYMErix  Phase 4 Study 8 th Q Report (01/21/02) Subjects accrued to date Vaccinees 7,643 Unexposed 21,580 ICD-9 codes - musculoskeletal 8472,063 1 st level reviewed nd level reviewed2432 New Onset Inflammatory arthropathy 715

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 THE END