Drugs / Ledipasvir/Sofosbuvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | chronic hepatitis C virus infection | 2014-09-24 | “Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir” gilead.com ↗ |
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | — | “The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | — | “The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02597166 | Jan 2016 → Jun 2018 | chronic hepatitis C virus infection, cirrhosis of liver | University Health Network, Toronto | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
The non-steroidal FXR agonist GS-9674 leads to significant reductions in hepatic steatosis, serum bile acids, and liver biochemistry in a Phase 2, randomized, placebo-controlled trial of pati |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗ |
| 2016-02-16 | Gilead Sciences | Regulatory U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved additional indications for Harvoni ® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. |
| 2014-09-24 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval |
| 2014-06-27 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Sofosbuvir for Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir, a once-daily nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. |
| 2014-06-15 | Gilead Sciences | Results Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan gilead.com ↗
Among patients receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C gilead.com ↗ |
| 2014-04-02 | Gilead Sciences | Results Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan gilead.com ↗
The study met its primary efficacy endpoint of superiority compared to a predefined historical control sustained virologic response (SVR) rate. |
All press releases naming this drug 18 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 | Ledipasvir/Sofosbuvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02597166 ↗ |
| Action | Inhibit | “prevents the hepatitis C virus from copying and multiplying themselves” NCT02597166 ↗ |
| Route | Oral | “given orally” NCT02597166 ↗ |