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Literature DB >> 29288370

Letermovir: First Global Approval.

Abstract

Letermovir (Prevymis™) is an orally or intravenously administered cytomegalovirus (CMV) DNA terminase complex inhibitor being developed by Merck & Co., Inc., under a global license from AiCuris Anti-infective Cures GmbH. Letermovir has been approved in Canada and the USA for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT). In addition, letermovir has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, and is under review in several countries, including Japan. This article summarizes the milestones in the development of letermovir leading to its first global approval in Canada as well as the USA for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT.

Entities: Chemical Disease Species

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Year: 2018 PMID： 29288370 DOI： 10.1007/s40265-017-0860-8

Source DB: PubMed Journal: Drugs ISSN： 0012-6667 Impact factor: 9.546

14 in total

1. The novel anticytomegalovirus compound AIC246 (Letermovir) inhibits human cytomegalovirus replication through a specific antiviral mechanism that involves the viral terminase.

Authors: Thomas Goldner; Guy Hewlett; Nicole Ettischer; Helga Ruebsamen-Schaeff; Holger Zimmermann; Peter Lischka
Journal: J Virol Date: 2011-07-13 Impact factor: 5.103

2. First report of successful treatment of multidrug-resistant cytomegalovirus disease with the novel anti-CMV compound AIC246.

Authors: D R Kaul; S Stoelben; E Cober; T Ojo; E Sandusky; P Lischka; H Zimmermann; H Rubsamen-Schaeff
Journal: Am J Transplant Date: 2011-05 Impact factor: 8.086

3. In vitro drug combination studies of Letermovir (AIC246, MK-8228) with approved anti-human cytomegalovirus (HCMV) and anti-HIV compounds in inhibition of HCMV and HIV replication.

Authors: Steffen Wildum; Holger Zimmermann; Peter Lischka
Journal: Antimicrob Agents Chemother Date: 2015-03-16 Impact factor: 5.191

4. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation.

Authors: Francisco M Marty; Per Ljungman; Roy F Chemaly; Johan Maertens; Sanjeet S Dadwal; Rafael F Duarte; Shariq Haider; Andrew J Ullmann; Yuta Katayama; Janice Brown; Kathleen M Mullane; Michael Boeckh; Emily A Blumberg; Hermann Einsele; David R Snydman; Yoshinobu Kanda; Mark J DiNubile; Valerie L Teal; Hong Wan; Yoshihiko Murata; Nicholas A Kartsonis; Randi Y Leavitt; Cyrus Badshah
Journal: N Engl J Med Date: 2017-12-06 Impact factor: 91.245

5. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation.

Authors: Roy F Chemaly; Andrew J Ullmann; Susanne Stoelben; Marie Paule Richard; Martin Bornhäuser; Christoph Groth; Hermann Einsele; Margarida Silverman; Kathleen M Mullane; Janice Brown; Horst Nowak; Katrin Kölling; Hans P Stobernack; Peter Lischka; Holger Zimmermann; Helga Rübsamen-Schaeff; Richard E Champlin; Gerhard Ehninger
Journal: N Engl J Med Date: 2014-05-08 Impact factor: 91.245

6. In vitro and in vivo activities of the novel anticytomegalovirus compound AIC246.

Authors: Peter Lischka; Guy Hewlett; Tobias Wunberg; Judith Baumeister; Daniela Paulsen; Thomas Goldner; Helga Ruebsamen-Schaeff; Holger Zimmermann
Journal: Antimicrob Agents Chemother Date: 2010-01-04 Impact factor: 5.191

7. Preemptive treatment of Cytomegalovirus infection in kidney transplant recipients with letermovir: results of a Phase 2a study.

Authors: Susanne Stoelben; Wolfgang Arns; Lutz Renders; Jürgen Hummel; Anja Mühlfeld; Manfred Stangl; Michael Fischereder; Wilfried Gwinner; Barbara Suwelack; Oliver Witzke; Michael Dürr; Dietrich W Beelen; Detlef Michel; Peter Lischka; Holger Zimmermann; Helga Rübsamen-Schaeff; Klemens Budde
Journal: Transpl Int Date: 2014-01 Impact factor: 3.782

Review 8. Treatment of CMV infection after allogeneic hematopoietic stem cell transplantation.

Authors: Enrico Maffini; Luisa Giaccone; Moreno Festuccia; Lucia Brunello; Alessandro Busca; Benedetto Bruno
Journal: Expert Rev Hematol Date: 2016-04-18 Impact factor: 2.929

9. Pharmacokinetics and Safety of Letermovir Coadministered With Cyclosporine A or Tacrolimus in Healthy Subjects.

Authors: Dirk Kropeit; Oliver von Richter; Hans-Peter Stobernack; Helga Rübsamen-Schaeff; Holger Zimmermann
Journal: Clin Pharmacol Drug Dev Date: 2017-10-02

10. Geno- and phenotypic characterization of human cytomegalovirus mutants selected in vitro after letermovir (AIC246) exposure.

Authors: Thomas Goldner; Christine Hempel; Helga Ruebsamen-Schaeff; Holger Zimmermann; Peter Lischka
Journal: Antimicrob Agents Chemother Date: 2013-11-04 Impact factor: 5.191

15 in total

1. Advances in the Development of Therapeutics for Cytomegalovirus Infections.

Authors: Edward Acosta; Terry Bowlin; Jennifer Brooks; Lillian Chiang; Islam Hussein; David Kimberlin; Lawrence M Kauvar; Randi Leavitt; Mark Prichard; Richard Whitley
Journal: J Infect Dis Date: 2020-03-05 Impact factor: 5.226

2. 4,5-Dihydroxypyrimidine Methyl Carboxylates, Carboxylic Acids, and Carboxamides as Inhibitors of Human Cytomegalovirus pUL89 Endonuclease.

Authors: Tianyu He; Tiffany C Edwards; Jiashu Xie; Hideki Aihara; Robert J Geraghty; Zhengqiang Wang
Journal: J Med Chem Date: 2022-04-04 Impact factor: 8.039

Review 3. In-depth summary over cytomegalovirus infection in allogeneic hematopoietic stem cell transplantation recipients.

Authors: Samira Karami; Elham Roshandel; Haniyeh Ghaffari Nazari; Abbas Hajifathali; Farzaneh Tavakoli; Sayeh Parkhideh
Journal: Virusdisease Date: 2021-07-28

4. Impact of Amino Acid Substitutions in Region II and Helix K of Herpes Simplex Virus 1 and Human Cytomegalovirus DNA Polymerases on Resistance to Foscarnet.

Authors: Karima Zarrouk; Xiaojun Zhu; Van Dung Pham; Nathalie Goyette; Jocelyne Piret; Rong Shi; Guy Boivin
Journal: Antimicrob Agents Chemother Date: 2021-06-17 Impact factor: 5.191

5. Outcomes of transplant recipients treated with cidofovir for resistant or refractory cytomegalovirus infection.

Authors: Seema A Mehta Steinke; Mona Alfares; Alexandra Valsamakis; Shmuel Shoham; Ravit Arav-Boger; Laura Lees; Darin Ostrander; Michael S Forman; Audra Shedeck; Richard F Ambinder; Richard John Jones; Robin K Avery
Journal: Transpl Infect Dis Date: 2020-12-02

6. Releasing the concept of HLA-allele specific peptide anchors in viral infections: A non-canonical naturally presented human cytomegalovirus-derived HLA-A*24:02 restricted peptide drives exquisite immunogenicity.

Authors: Wiebke C Pump; Rebecca Schulz; Trevor Huyton; Heike Kunze-Schumacher; Jörg Martens; Gia-Gia T Hò; Rainer Blasczyk; Christina Bade-Doeding
Journal: HLA Date: 2019-04-14 Impact factor: 4.513