Drugs / Sofosbuvir/Velpatasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2015-11-17 | “Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05140941 | Apr 2022 → Aug 2026 overdue | chronic hepatitis C virus infection | Catherine Anne Chappell | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Meets Both Its Primary and Secondary Endpoints in the Phase 3 C-BEYOND North America Trial Evaluating Bemnifosbuvir/Ruzasvir for Hepatitis C Virus ateapharma.com ↗
In the mITT analysis (n=905, cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate vs. 94.8% for SOF/VEL (Epclusa) at Week 24, encompassing SVR at 12 weeks post-treatment (accepted definition of cure for HCV) in both arms. |
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe |
| 2021-06-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C gilead.com ↗
The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. |
| 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. |
| 2017-06-23 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes gilead.com ↗
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. |
| 2016-10-20 | Gilead Sciences | Results Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients gilead.com ↗
Based on these Phase 3 results, we plan to submit regulatory applications for SOF/VEL/VOX for the treatment of chronic HCV in the United States in the fourth quarter of 2016 and shortly thereafter in Europe. |
| 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 . |
| 2015-12-04 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C gilead.com ↗ |
| 2015-10-28 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C gilead.com ↗
The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. |
| 2015-09-21 | Gilead Sciences | Results Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes gilead.com ↗ |
All press releases naming this drug 23 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sofosbuvir/Velpatasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05140941 ↗ |
| Known as | SOF/VEL | “This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy.” NCT05140941 ↗ |
| Route | Oral | “Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet” NCT05140941 ↗ |