Drugs / Letermovir
Letermovir
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cytomegalovirus infection 2 milestones | |||||
| Filed | EU (EMA) | — | cytomegalovirus infection | — | “Merck has regulatory applications pending in other markets, including in the European Union and Japan.” merck.com ↗ |
| Filed | Japan (PMDA) | — | cytomegalovirus infection | — | “Merck also has filed letermovir for regulatory approval in other markets including Japan, where it is currently under review.” merck.com ↗ “Merck has regulatory applications pending in other markets, including in the European Union and Japan.” merck.com ↗ |
| Filed idiopathic disseminated cytomegalovirus infection 1 milestone | |||||
| Filed | US (FDA) | PREVYMIS | idiopathic disseminated cytomegalovirus infection | 2023-02-17 | “today announced the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir).” merck.com ↗ “The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | PREVYMIS | — | 2023-06-05 – 2024-08-30 | fda.gov ↗ |
| Approved | EU (EMA) | Prevymis | — | 2018-01-08 | europa.eu ↗ |
| Approved | US (FDA) | PREVYMIS | — | 2017-11-08 | fda.gov ↗ |
Trials 45
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2024-07-17 | AiCuris Anti-infective Cures AG | Regulatory Aicuris Announces Milestone Achievements Further Validating its Pipeline of Anti-viral Solutions for Immuno-compromised Patients aicuris.com ↗
PREVYMIS® (letermovir) gains approval in Japan for prevention of cytomegalovirus disease in adult patients with a solid organ transplant (SOT) triggering next milestone payment of EUR €7.5 million from partner MSD |
| 2024-06-03 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Letermovir Tablets lupin.com ↗ |
| 2024-03-23 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Letermovir Tablets, 240 mg and 480 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Letermovir tablets, 240 mg and 480 mg, (USRLD: Prevymis® tablets). |
| 2024-01-09 | AiCuris Anti-infective Cures AG | Regulatory Aicuris Received 15 Million Euros Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS® for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients aicuris.com ↗
PREVYMIS® now approved in the U.S. and Europe for prophylaxis of Cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R?]) |
| 2023-10-17 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Late CMV Infection and Disease merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PREVYMIS ® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]). |
| 2023-08-23 | AiCuris Anti-infective Cures AG | Regulatory Aicuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS® (letermovir) in Second Indication aicuris.com ↗
Aicuris Anti-infective Cures AG, a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients, announced today that it has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (NYSE: MRK)) following U.S. Food and Drug Administration (FDA) approval for first-in-class antiviral agent PREVYMIS ® in a new indication – the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients. |
| 2023-06-06 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a new indication for PREVYMIS ® (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review. |
| 2023-02-17 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck’s PREVYMIS™ for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir). |
| 2022-10-22 | Merck Sharp & Dohme LLC | Results Merck’s PREVYMIS™ Demonstrates Efficacy in Phase 3 Study for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation merck.com ↗
In a pre-specified safety analysis, PREVYMIS-treated participants had significantly less myelotoxicity, as measured by rates of leukopenia or neutropenia, compared to valganciclovir-treated participants; 26.0% (n=76) versus 64.0% (n=190), (95% CI, -45.1, -30.3; p-value <0.0001). |
| 2022-04-28 | Merck Sharp & Dohme LLC | Results Merck Announces First-Quarter 2022 Financial Results merck.com ↗
PREVYMIS was approved by the FDA in 2017. |
| 2022-03-22 | Merck Sharp & Dohme LLC | Results Systematic Review and Meta-Analysis of Real-World Observational Studies Provide Additional Evidence of Effectiveness of PREVYMIS™ in Preventing Cytomegalovirus Infection and Disease in Adults Undergoing Allogeneic HCT merck.com ↗
Consistent results were observed at 200 days of follow-up with respect to CMV reactivation, clinically significant CMV infection, and CMV disease. |
| 2017-12-06 | Merck Sharp & Dohme LLC | Results New England Journal of Medicine Publishes Phase 3 Clinical Study of PREVYMIS™ (letermovir), Merck’s New CMV Prophylaxis Medicine merck.com ↗
In the study, significantly fewer patients in the PREVYMIS arm (37.5%, n=122/325) compared to the placebo arm (60.6%, n=103/170) developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-transplant (p<0.001), the primary efficacy endpoint. |
| 2017-11-13 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for PREVYMIS™ (letermovir) in the European Union merck.com ↗
The CHMP positive opinion will be considered by the European Commission. |
| 2017-11-09 | Merck Sharp & Dohme LLC | Regulatory Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients merck.com ↗
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. |
| 2017-02-26 | Merck Sharp & Dohme LLC | Results Merck’s Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus (CMV) Infection in Bone Marrow Transplant Recipients, Highly Effective Through Week 24 Post-Transplant in Pivotal Phase 3 Study merck.com ↗
In the study, letermovir prophylaxis was associated with lower all-cause mortality through Week 24 post-HSCT. |
| 2016-10-19 | Merck Sharp & Dohme LLC | Results Merck Announces Pivotal Phase 3 Study of Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus (CMV) Infection in High-Risk Bone Marrow Transplant Patients, Met Primary Endpoint merck.com ↗
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine, met its primary endpoint. |
| 2014-05-08 | Merck Sharp & Dohme LLC | Results AiCuris and Merck Announce Publication in New England Journal of Medicine of Phase 2 Clinical Trial Results of Investigational Antiviral Agent Letermovir in Bone Marrow Transplant Patients merck.com ↗
The results published in the latest issue of the N ew England Journal of Medicine (NEJM) show that letermovir in CMV-seropositive allogeneic human blood precursor cell recipients (bone marrow transplant patients) met the study’s two primary efficacy endpoints. |
All press releases naming this drug 18 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Letermovir | “A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention...” NCT03443869 ↗47“Patients received oral letermovir (at a dose of 60, 120, or 240 mg per day, or matching placebo) for 12 weeks after engraftment.” PMID 24806159 ↗ May 2014 |
| Known as | AIC246 | “we evaluated the effect of letermovir (also known as AIC246), a new anti-CMV drug with a novel mechanism of action” PMID 24806159 ↗ May 2014 |
| Known as | LET | “This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of...” NCT05626530 ↗ |
| Known as | Letermovir Tablets | “Letermovir Tablets” NCT06021210 ↗ |
| Known as | LTM | “Letermovir (LTM) is a new anti CMV drug, manufactured by Merck that:” NCT04732260 ↗ |
| Known as | LTV | “Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT.” NCT06449586 ↗ |
| Known as | MK-8228 | “A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention...” NCT03443869 ↗ |
| Known as | Prevymis | “Letermovir 480 MG [Prevymis]” NCT06066957 ↗1“Letermovir 480 mg [PREVYMIS]” NCT07101055 ↗ |
| Action | Inhibit | “Letermovir is an antiviral drug that inhibits the CMV-terminase complex.” PMID 29211658 ↗ Dec 2017 |
| Modality | Small molecule | — CHEMBL1241951 ↗ |
| Route | Oral | “Patients received oral letermovir (at a dose of 60, 120, or 240 mg per day, or matching placebo) for 12 weeks after engraftment.” PMID 24806159 ↗ May 2014 |