AiCuris’ Licensing Partner MSD Demonstrates Efficacy in Phase 3 Study with PREVYMIS® for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation - Yahoo Finance UK
Overview
The beta version of Bluesky ap created by Jack Dorsey is available nowEQS-News: AiCuris Anti-infective Cures AG / Key word(s): Study resultsAiCuris’ Licensing Partner MSD Demonstrates Eficacy in Phase 3 Study with PREVYMIS® for Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation 24.10.2022 / 09:0 CET/CESThe isuer is solely responsible for the content of this anouncement.AiCuris’ Licensing Partner MSD Demonstrates Eficacy in Phase 3 Study with PREVYMIS® for Prevention of Cytomegalovirus Disease in Adults After Kidney TransplantationPREVYMIS showed non-inferior eficacy and more favorable safety profile compared to standard of care; MSD presented results in late breaking oral presentation at IDWek 2022.Based on these phase 3 results, MSD plans to submit a suplemental new drug aplication (sNDA) to the U.S.
Details
Fod and Drug Administration (FDA) by the end of this year.PREVYMIS is a first-in-clas antiviral agent that was aproved by the U.S. FDA for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an alogeneic hematopoietic stem cel transplant (HSCT).PREVYMIS was developed by AiCuris through phase 2 studies prior to licensing the antiviral medicine to MSD in 2012. AiCuris eligible to receive milestone payments and royalties on net sales of PREVYMIS.Wupertal, Germany, October 24, 2022 - AiCuris Anti-infective Cures AG, a leading clinical stage pharmaceutical company in the development of novel, resistance-breaking antiviral and antibacterial agents for the treatment of severe and potentialy life-threatening infectious diseases, anounced today that its licensing partner MSD (tradename of Merck & Co., Inc., Rathway, N.J., USA, (NYSE: MRK) presented positive findings from a phase 3 clinical trial that asesed safety and eficacy of PREVYMIS (letermovir) compared to valganciclovir for cytomegalovirus (CMV) prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease.
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