Drugs / Harvoni

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Harvoni — 2014-11-17 europa.eu ↗
Approved US (FDA) HARVONI — 2014-10-10 fda.gov ↗

Trials 3

2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
Phase 2/3 NCT02825212 Feb 2016 → Jul 2019 chronic hepatitis C virus infection, cryoglobulinemia Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02759861 Aug 2016 → Aug 2020 chronic hepatitis C virus infection University of Nebraska Completed No outcome recorded
Phase 4 NCT02533934 Aug 2016 → Dec 2019 HIV infectious disease, cirrhosis of liver, hepatitis C virus infection University of California, San Francisco Completed No outcome recorded

Press releases naming this drug 14 releases

DateIssuerRelease
2018-12-04 Gilead Sciences China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com ↗
2018-09-24 Gilead Sciences Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗
2017-04-21 Gilead Sciences Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
2017-04-07 Gilead Sciences U.S. FDA Approves New Indications for Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection gilead.com ↗
2016-02-16 Gilead Sciences U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
2015-11-12 Gilead Sciences U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C gilead.com ↗
2015-07-03 Gilead Sciences Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2015-04-23 Gilead Sciences Gilead’s Harvoni and Sovaldi Demonstrate Efficacy and Safety among Chronic Hepatitis C Patients with Advanced Liver Disease gilead.com ↗
2015-02-26 Gilead Sciences Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV gilead.com ↗
2014-11-18 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 gilead.com ↗
2014-11-11 Gilead Sciences Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment gilead.com ↗
2014-10-16 Gilead Sciences Health Canada Issues Notice of Compliance for Gilead’s Harvoni™ (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as Harvoni ClinicalTrials.gov intervention name — accepted as the source's own label NCT02533934 ↗
2

NCT02825212 ↗

NCT02759861 ↗