Drugs / SOF/VEL/VOX
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03820258 | Jan → Dec 2019 | hepatitis C virus infection | Gilead Sciences | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2017-07-28 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
European Commission Also Extends Marketing Authorization for Harvoni ® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients |
| 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. |
| 2017-05-02 | Gilead Sciences | Regulatory Gilead Sciences Announces First Quarter 2017 Financial Results gilead.com ↗
Announced that the marketing authorization application for the investigational, once-daily, single-tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of HCV-infected patients has been fully validated and is under assessment by the European Medicines Agency . |
| 2017-01-20 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (EMA). |
| 2016-12-08 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir gilead.com ↗ |
| 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. |
All press releases naming this drug 7 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/VOX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03820258 ↗ |
| Known as | Sofosbuvir/Velpatasvir/Voxilaprevir | “Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With...” NCT03820258 ↗ |