Drugs / sofosbuvir/velpatasvir
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” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03018353 | Mar 2017 → Mar 2018 | chronic hepatitis C virus infection | San Francisco Department of Public Health | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 2020-03-19 | Gilead Sciences | Regulatory U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.com ↗ |
| 2019-10-30 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Announces New Data on CC-31244 and Abstract Acceptance for Poster Presentation at the AASLD 2019 Liver Meeting cocrystalpharma.com ↗
Eight of 12 patients achieved primary endpoint of sustained virologic response (SVR) 12, which is considered a cure, using only 6 weeks of Epclusa’s therapy combined with only 2 weeks of CC-31244 |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗ |
| 2019-01-08 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.com ↗ |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from studies investigating Epclusa ® (sofosbuvir 400mg/velpatasvir 100mg) in chronic hepatitis C virus (HCV) infected patients with severe renal impairment undergoing dialysis and Harvoni ® (ledipasvir/sofosbuvir) in pediatric HCV patients aged three to five years, adding to the efficacy and safety profile of sofosbuvir-based regimens across diverse patient populations. |
| 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) |
| 2018-05-30 | Gilead Sciences | Regulatory China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug Administration (CDA) has approved Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
Positive results from studies of Harvoni ® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa ® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22 . |
| 2017-08-01 | Gilead Sciences | Regulatory U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.com ↗ |
| 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. |
| 2016-06-28 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. |
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 | “The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during...” NCT03018353 ↗ |
| Known as | Epclusa | “patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa).” NCT03018353 ↗ |
| Route | Oral | “FDA approved combination oral treatment” NCT03018353 ↗ |