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 | “Announced that the company’s Marketing Authorisation Application for LDV/SOF has been fully validated and is now under assessment by the European Medicines Agency .” 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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02202980 | Aug 2014 → Mar 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-04-21 | Gilead Sciences | Results Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
The studies demonstrated HCV cure rates of 99 percent in children aged 6 to 11 years (#PS-101), and 100 percent in adult patients co-infected with HCV and hepatitis B virus (HBV) (#PS-098). |
| 2014-03-27 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection gilead.com ↗
LDV/SOF Granted an Accelerated Assessment by the European Medicines Agency |
| 2014-02-10 | Gilead Sciences | Regulatory Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02202980 ↗ |
| Known as | ledipasvir-sofosbuvir | “The first received a fixed-dose combination tablet of ledipasvir-sofosbuvir (90/400 mg) once daily for 12 weeks.” PMID 28137593 ↗ Jan 2017 |
| Route | Oral | “90/400 mg FDC tablet administered orally once daily” NCT02202980 ↗ |