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Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients

Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients. William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products HFD-550. Approved Products. Cytovene-IV (ganciclovir) Foscavir Injection (foscarnet)

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Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients

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  1. Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products HFD-550

  2. Approved Products • Cytovene-IV (ganciclovir) • Foscavir Injection (foscarnet) • Cytovene Capsules (ganciclovir) • Vitrasert Implant (ganciclovir) • Vistide Injection (cidofovir) • Vitravene for Injection (fomvirsen)

  3. Cytovene-IV (ganciclovir) • Approved June 23, 1989 • Clinical Data Source(s) for Approval • Study #1 - randomized, controlled trial, immediate versus delayed treatment (N = 42) • Study #2 - nonrandomized, retrospective, immediate versus delayed treatment (N = 41)

  4. Cytovene-IV (ganciclovir) • Primary Endpoints for Study #1 and #2: • Time to progression of CMV retinitis • Primary Endpoint Analysis • Study #1 (photos): median time to progression of 50 days for immediate treatment; 14 days for delayed • Study #2 (exam): median time to progression of 71 days for immediate treatment; 29 days for delayed

  5. Foscavir Injection (foscarnet) • Approved September 27, 1991 • Clinical Data Source(s) for Approval • randomized, open label, controlled trial, immediate versus delayed treatment (N = 24) • Primary Endpoint • Time to progression of CMV retinitis

  6. Foscavir Injection (foscarnet) • Primary Endpoint Analysis • median time to progression of 93 days for immediate treatment; 22 days for delayed (photos)

  7. Cytovene Capsules (ganciclovir) • Approved December 22, 1994 • Not approved for induction due to poor bioavailability (5% available) • Study Design for Maintenance Indication • three randomized, open label trials with Cytovene-IV as comparator (N total = 505)

  8. Vitrasert Implant (ganciclovir) • Approved March 4, 1996 • Clinical Data Source(s) for Approval • randomized, parallel, ganciclovir implant versus ganciclovir IV (N =188) • Primary Endpoint • Time to progression of CMV retinitis

  9. Vitrasert Implant (ganciclovir) • Primary Endpoint Analysis • median time to progression of 210 days for immediate treatment; 120 days for delayed (photos)

  10. Vistide Injection (cidofovir) • Approved June 26, 1996 • Clinical Data Source(s) for Approval • randomized, open label, controlled trial, immediate versus delayed treatment (N = 48) • Primary Endpoint • Time to progression of CMV retinitis

  11. Vistide Injection (cidofovir) • Primary Endpoint Analysis • median time to progression of 120 days for immediate treatment; 22 days for delayed (photos)

  12. Vitravene for Injection (fomvirsen) • Approved August 26, 1998 • Clinical Data Source(s) for Approval • limited, open label, controlled clinical studies, immediate versus delayed treatment (N = 80 eyes) • Primary Endpoint • Time to progression of CMV retinitis

  13. Vitravene for Injection (fomvirsen) • Primary Endpoint Analysis • median time to progression of 80 days for immediate treatment; 14 days for delayed (photos)

  14. Approved Products

  15. Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products HFD-550

  16. Valcyt 450 mg Tablets (valganciclovir hydrochloride) NDA 21-304

  17. valganciclovir tablets • NDA submitted September 28, 2000 • Clinical Data Source(s) for Approval • randomized, open label, parallel group, valganciclovir versus ganciclovir IV (N=160) • Primary Endpoint • proportion of patients with disease progression at week 4

  18. valganciclovir tablets • Primary Endpoint Analysis • 7 subjects in valganciclovir arm and 7 subjects in the ganciclovir treatment arm had CMV progression at week 4 (photos)

  19. valganciclovir tabletsAnalysis of CMV Retinitis Progression by Week 4 Compared to Baseline(Medical Officer’s Masked Photographic Assessment)

  20. valganciclovir tablets

  21. valganciclovir tablets

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