Foster City, Calif., October 20, 2021 –Gilead today announced it will not pursue a marketing authorization for Descovy®(emtricitabine 200 mg/tenofovir alafenamide 25 mg) for pre-exposure prophylaxis (PrEP) in the European Union (EU) at this time. Conversations with healthcare professionals, payers and other stakeholders across Europe have confirmed there is a lack of demand for innovative daily PrEP options given the broad availability of generic alternatives. Policies and decisions made by national governments relating to reimbursement can adversely impact the feasibility of pursuing marketing authorization in each market. This is the case in the EU.
Gilead also announced it will submit a study protocol amendment to local EU health authorities to extend the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy for PrEP® compared with Truvada®(emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) (Truvada for PrEP®), in men and transgender women who have sex with men and may benefit from PrEP medicines. The proposed DISCOVER extension will go through September 2027 and will provide 264 weeks (five years) of additional data (with nearly eight years of Descovy open label extension), to further inform clinical and reimbursement decisions regarding daily oral PrEP options and allow current DISCOVER participants to retain access to Descovy for PrEP.
Gilead remains deeply committed to scientific innovation and the development of novel PrEP options with the goal of achieving zero new HIV infections. To help ensure sustainable access to new PrEP options for all who can benefit, we will continue to pursue marketing authorizations in countries where payers recognize the public health and individual value of HIV prevention.
For information about the approved uses and important safety information for Descovy (emtricitabine and tenofovir alafenamide; 200/25 mg), and for Truvada (emtricitabine and tenofovir disoproxil fumarate; 200/300 mg), please see the full Prescribing Information including BOXED WARNINGS for each product, available at Gilead.com.
Please see here for U.S. Indications and Important Safety Information, including Boxed Warnings, for Descovy for PrEP® and Truvada for PrEP®.
There is no cure for HIV or AIDS.
Source : Gilead Sciences, Inc.
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