Drugs / F/TAF
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | HIV infectious disease | 2015-05-28 | “Gilead’s Marketing Authorization Application (MAA) for two doses of F/TAF (200/10 mg and 200/25 mg) was fully validated and under evaluation by the European Medicines Agency .” gilead.com ↗ “A Marketing Authorization Application (MAA) in the European Union for F/TAF was fully validated on May 28, 2015 .” gilead.com ↗ “F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA).” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2015-04-07 | “In April 2015 , Gilead filed a New Drug Application (NDA) with the U.S. Food and Drug Administration ( FDA ) for two fixed-dose combinations of F/TAF” gilead.com ↗ “This was Gilead's second F/TAF-based NDA submitted to the FDA for review.” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-07-25 | Gilead Sciences | Results Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
Results showed that GS-1720 was generally well tolerated across the doses tested and exhibited a half-life that may be supportive of once-weekly oral dosing. |
| 2022-10-18 | Gilead Sciences | Results Gilead Presents Real-World and Long-Term Data From HIV Research Programs at HIV Glasgow 2022 gilead.com ↗
A pooled analysis of eight clinical studies suggests a link between influenza-like adverse events and pharmacodynamics of the TLR7 agonist vesatolimod |
| 2022-07-21 | Gilead Sciences | Results Scientific Innovation and Collaboration Highlighted at AIDS 2022 as Gilead Extends Leadership Efforts Toward Ending the Global HIV Epidemic gilead.com ↗
Early data identifying potential biomarkers associated with time-to-HIV-rebound (TTHR) post-antiretroviral therapy (ART) interruption following treatment with Gilead’s investigational TLR-7 agonist, vesatolimod. |
| 2020-03-10 | Gilead Sciences | Results Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations gilead.com ↗
At both Weeks 48 and 96, Descovy for PrEP demonstrated non-inferior efficacy to Truvada for PrEP. |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. |
| 2019-10-04 | Gilead Sciences | Results Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019 gilead.com ↗
Results from DISCOVER Trial Provide Bone and Renal Safety Profile Data from Participants who Switched from Truvada for PrEP ® to Descovy for PrEP ™ |
| 2019-08-07 | Gilead Sciences | Regulatory Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™ gilead.com ↗
the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration ( FDA ) recommended approval of Descovy ® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) |
| 2019-07-23 | Gilead Sciences | Results Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗
At Week 4, levels of TFV-DP in PBMCs were 6.3-fold higher with Descovy compared with Truvada, resulting in 98 percent of participants receiving Descovy had drug levels above the EC90 compared with 68 percent of participants taking Truvada. |
| 2016-02-23 | Gilead Sciences | Results Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens gilead.com ↗
At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | F/TAF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06337032 ↗ |
| Route | Oral | “200/25 mg fixed-dose combination (FDC) tablet administered orally” NCT06337032 ↗ |