Drugs / SOF/VEL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “Gilead filed the NDA for SOF/VEL on October 28, 2015 , and FDA has set a target action date” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02996682 | Dec 2016 → Feb 2018 | chronic hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
Additionally, a retrospective analysis of participants enrolled in two Phase 3 studies evaluating Vemlidy ® (tenofovir alafenamide) using a risk score for liver cancer highlights the importance of treatment to help reduce liver cancer risk. |
| 2022-06-21 | Gilead Sciences | Results Gilead to Present Latest Data From Across Liver Disease Development Programs at the International Liver Congress™ 2022 gilead.com ↗
Real-world evidence from the Kaiser Permanente Southern California healthcare system will also be presented (Poster 2954), showing a reduction in HCV-related morbidity and mortality, and a significant improvement in quality-adjusted life-years (QALYs) in patients treated with DAAs like sofosbuvir/velpatasvir. |
| 2020-08-25 | Gilead Sciences | Results Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020 gilead.com ↗
A large real-world dataset of 1,888 adults from 33 clinical cohorts found a 98% sustained virologic response (SVR) rate among the effectiveness population (defined as patients achieving SVR or having virologic failure) with Epclusa for 12 weeks across these key underserved patient populations. |
| 2016-05-27 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗
Data were presented this week at The International Liver Congress TM 2016 in Barcelona, Spain . |
All press releases naming this drug 6 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 | SOF/VEL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02996682 ↗ |
| Route | Oral | “administered orally once daily” NCT02996682 ↗ |