LYMErix Lyme Disease Vaccine Recombinant Osp A

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