Drugs / LDV/SOF
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 | 2014-02-27 | “Marketing Authorisation Application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor...” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2014-02-10 | “On February 10, 2014 , Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for the LDV/SOF fixed-dose combination tablet” gilead.com ↗ “Gilead filed the NDA for LDV/SOF on February 10, 2014 , and the FDA has set a target action date” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02251717 | Oct 2014 → Mar 2016 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-04-10 | Gilead Sciences | Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C gilead.com ↗ |
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 | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02251717 ↗ |
| Known as | Ledipasvir-Sofosbuvir | “This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with...” NCT02251717 ↗ |
| Route | Oral | “90/400 mg FDC tablet administered orally once daily” NCT02251717 ↗ |