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 | “The data included in the application, which was submitted on November 17, 2015 , support the use of SOF/VEL among patients with genotype 1-6 HCV infection” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “submitted a New Drug Application to FDA for an investigational, once-daily fixed-dose combination of SOF/VEL” gilead.com ↗ “Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02728206 | Jun 2016 → Jan 2018 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 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 |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis (poster #0138) |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15) |
| 2016-07-08 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
All press releases naming this drug 19 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 | “sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination” NCT02728206 ↗ |
| Known as | SOF/VEL | “sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination” NCT02728206 ↗ |
| Route | Oral | “administered orally” NCT02728206 ↗ |