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Prevymis Approval History

  • FDA approved: Yes (First approved November 8th, 2017)
  • Brand name: Prevymis
  • Generic name: letermovir
  • Dosage form: Tablets and Injection
  • Company: Merck & Co., Inc.
  • Treatment for: CMV Prophylaxis

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult allogeneic hematopoietic stem cell transplant patients.

Development History and FDA Approval Process for Prevymis

DateArticle
Nov  9, 2017Approval FDA Approves Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
Feb 26, 2017Merck’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
Oct 19, 2016Merck Announces Pivotal Phase 3 Study of Letermovir Met Primary Endpoint
Jul 24, 2014Merck Initiates Phase 3 Study of Letermovir for Prevention of Cytomegalovirus (CMV) Infection
May  8, 2014AiCuris and Merck Announce Publication of Phase 2 Trial Results of Investigational Antiviral Letermovir
Feb 14, 2012AiCuris Drug Letermovir (AIC246) Meets Primary Efficacy Endpoints in Phase 2 For Human Cytomegalovirus (HCMV) Prophylaxis in Human Blood Precursor Cell Recipients

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