segunda-feira, março 14, 2005
Roche anuncia discontinuação de Hivid e Fortovase
F-Hoffmann -La Roche LTD
Basel 4070 CH, 11 March 2005.
As part of its regular review of products in its pharmaceutical portfolio, Roche has initiated discussions with worldwide regulatory authorities on plans to discontinue two of its HIV drugs, Hivid® (zalcitabine) and Fortovase® (saquinavir, soft capsule formulation), in the near future.
The decision has been made because of the availability of newer drugs that better meet physicians’ and patients’ needs and because they are excluded from the newest HIV treatment guidelines. Hivid use continues to decline due to the availability of newer NRTIs with enhanced safety and efficacy. The use of unboosted Fortovase has decreased because of its high pill count of 18 capsules a day and three-times daily dosing.
Boosted Invirase (saquinavir hard capsule formulation), on the other hand, has been shown to be better tolerated than boosted Fortovase and is today the preferred formulation of saquinavir. In fact, current HIV guidelines recommend to use boosted Invirase in combination with antiretroviral regimens. Finally, the introduction of the Invirase 500mg tablet will further reduce the use of Fortovase since the daily saquinavir pill count will be significantly reduced to only two Invirase 500mg pills twice daily*, making the treatment regimen more convenient for patients.
Roche will keep physicians and patient groups informed of decisions resulting from our discussions with health authorities. Any planned discontinuation will be undertaken in such a manner to allow physicians and patients adequate time to consider and transition to alternative treatment options.
Basel 4070 CH, 11 March 2005.
As part of its regular review of products in its pharmaceutical portfolio, Roche has initiated discussions with worldwide regulatory authorities on plans to discontinue two of its HIV drugs, Hivid® (zalcitabine) and Fortovase® (saquinavir, soft capsule formulation), in the near future.
The decision has been made because of the availability of newer drugs that better meet physicians’ and patients’ needs and because they are excluded from the newest HIV treatment guidelines. Hivid use continues to decline due to the availability of newer NRTIs with enhanced safety and efficacy. The use of unboosted Fortovase has decreased because of its high pill count of 18 capsules a day and three-times daily dosing.
Boosted Invirase (saquinavir hard capsule formulation), on the other hand, has been shown to be better tolerated than boosted Fortovase and is today the preferred formulation of saquinavir. In fact, current HIV guidelines recommend to use boosted Invirase in combination with antiretroviral regimens. Finally, the introduction of the Invirase 500mg tablet will further reduce the use of Fortovase since the daily saquinavir pill count will be significantly reduced to only two Invirase 500mg pills twice daily*, making the treatment regimen more convenient for patients.
Roche will keep physicians and patient groups informed of decisions resulting from our discussions with health authorities. Any planned discontinuation will be undertaken in such a manner to allow physicians and patients adequate time to consider and transition to alternative treatment options.
