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.

journal_name

Drugs

journal_title

Drugs

authors

Kim ES

doi

10.1007/s40265-017-0860-8

subject

Has Abstract

pub_date

2018-01-01 00:00:00

pages

147-152

issue

1

eissn

0012-6667

issn

1179-1950

pii

10.1007/s40265-017-0860-8

journal_volume

78

pub_type

杂志文章,评审

相关文献

DRUGS文献大全
  • Pimavanserin: First Global Approval.

    abstract::Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-016-0597-9

    authors: Markham A

    更新日期:2016-07-01 00:00:00

  • Low molecular weight heparins: a guide to their optimum use in pregnancy.

    abstract::The incidence of pulmonary embolism (PE) and venous thromboembolism (VTE) is higher in pregnant patients than in non-pregnant patients. The incidence of thrombosis in all pregnancies is reported to be between 0.05 and 1%, and an incidence as high as 3% may be present in women after caesarean section. Anticoagulant med...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200262030-00004

    authors: Laurent P,Dussarat GV,Bonal J,Jego C,Talard P,Bouchiat C,Cellarier G

    更新日期:2002-01-01 00:00:00

  • Pinacidil with and without hydrochlorothiazide. Dose-response relationships from results of a 4 x 3 factorial design study.

    abstract::Utilising a modified fixed-dose, 4 x 3 factorial design, the antihypertensive effects of all combinations of 4 doses of pinacidil (0, 12.5, 25 and 37.5 mg bid) with 3 doses of hydrochlorothiazide (0, 12.5 and 25 mg bid) were studied in patients with supine diastolic blood pressure of 95 to 110mm Hg. The decreases in s...

    journal_title:Drugs

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2165/00003495-198800367-00015

    authors: Goldberg MR,Offen WW

    更新日期:1988-01-01 00:00:00

  • Treatment of chronic schizophrenia.

    abstract::The comprehensive treatment of schizophrenia requires the full resources of a clinical team that is able to offer treatment for the acute psychotic state in a hospital environment, and appropriate rehabilitation following resolution of the florid symptoms. Following a second or subsequent relapse, maintenance therapy ...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-197714040-00004

    authors: Johnson DA

    更新日期:1977-10-01 00:00:00

  • Ceftriaxone: an update of its use in the management of community-acquired and nosocomial infections.

    abstract:UNLABELLED:Ceftriaxone is a parenteral third-generation cephalosporin with a long elimination half-life which permits once-daily administration. It has good activity against Streptococcus pneumoniae, methicillin-susceptible staphylococci, Haemophilus influenzae, Moraxella catarrhalis and Neisseria spp. Although active ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200262070-00005

    authors: Lamb HM,Ormrod D,Scott LJ,Figgitt DP

    更新日期:2002-01-01 00:00:00

  • Susoctocog Alfa: A Review in Acquired Haemophilia A.

    abstract::Intravenous susoctocog alfa (Obizur(®)) is a recombinant, B-domain deleted, porcine sequence antihaemophilic factor VIII (FVIII) product that has recently been approved for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). Intravenous susoctocog alfa was an effective and generally well to...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-016-0576-1

    authors: Burness CB,Scott LJ

    更新日期:2016-05-01 00:00:00

  • Teicoplanin. A reappraisal of its antimicrobial activity, pharmacokinetic properties and therapeutic efficacy.

    abstract::Since an earlier review in the Journal substantial additional data have accumulated, further clarifying the in vitro activity, pharmacokinetic profile, clinical efficacy and tolerability of teicoplanin. Recent therapeutic trials confirm the efficacy of teicoplanin in the treatment of microbiologically confirmed Gram-p...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199447050-00008

    authors: Brogden RN,Peters DH

    更新日期:1994-05-01 00:00:00

  • Platelets, thrombosis and drugs.

    abstract::The development of thrombosis involves 4 main factors: the vessel wall, the formed elements of the blood, blood coagulation, and blood flow. In venous thrombosis, however, the major part in both the initiation and growth of thrombi is played by the platelets. In selecting drugs which inhibit platelet function it is he...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-197509010-00003

    authors: Mustard JF,Packham MA

    更新日期:1975-01-01 00:00:00

  • Coronary thrombolysis for evolving myocardial infarction.

    abstract::An acute thrombus at the site of an atherosclerotic obstruction is the usual cause of myocardial infarction. Thrombolytic therapy is an exciting new therapy for reducing the extent of myocardial infarction by lysing intracoronary clots. Such therapy has now been widely applied by: prolonged intravenous infusion of str...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-198428050-00004

    authors: Spann JF,Sherry S

    更新日期:1984-11-01 00:00:00

  • Inhaled Umeclidinium in COPD Patients: A Review and Meta-Analysis.

    abstract::A number of new agents for the management of chronic obstructive pulmonary disease (COPD) are at different stages of development, including several inhaled long-acting antimuscarinics (LAMA). Long-acting bronchodilators are considered to be central to the management of COPD due to the evidence supporting their efficac...

    journal_title:Drugs

    pub_type: 杂志文章,meta分析,评审

    doi:10.1007/s40265-015-0532-5

    authors: Pleasants RA,Wang T,Gao J,Tang H,Donohue JF

    更新日期:2016-03-01 00:00:00

  • The challenge of changing healthcare systems.

    abstract::Healthcare systems are in flux throughout the world. Traditional structures and attitudes are changing. The balance of power between political bodies, payers, providers and patients is being destabilised. New approaches by governments and forward integration by drug companies and payers into care management are all ma...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-199600522-00014

    authors: Weber F

    更新日期:1996-01-01 00:00:00

  • Use of economic evaluation in decision making: evidence and recommendations for improvement.

    abstract::Information about the value for money of a medicine as derived from an economic evaluation can be used for decision-making purposes by policy makers, healthcare payers, healthcare professionals and pharmaceutical companies. This article illustrates the use of economic evaluation by decision makers and formulates a num...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/11538120-000000000-00000

    authors: Simoens S

    更新日期:2010-10-22 00:00:00

  • Correction to: Isatuximab: First Approval.

    abstract::In the table 'Key clinical trials of isatuximab (Sanofi)', in the left-hand column. ...

    journal_title:Drugs

    pub_type: 杂志文章,已发布勘误

    doi:10.1007/s40265-020-01325-9

    authors: Dhillon S

    更新日期:2020-06-01 00:00:00

  • Herb-drug interactions: a literature review.

    abstract::Herbs are often administered in combination with therapeutic drugs, raising the potential of herb-drug interactions. An extensive review of the literature identified reported herb-drug interactions with clinical significance, many of which are from case reports and limited clinical observations. Cases have been publis...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200565090-00005

    authors: Hu Z,Yang X,Ho PC,Chan SY,Heng PW,Chan E,Duan W,Koh HL,Zhou S

    更新日期:2005-01-01 00:00:00

  • Transdermal Nicotine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy as an aid to smoking cessation.

    abstract::Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin. The partial replacement of plasma nicotine, which would have otherwise been obtained from cigarettes, reduces the severity of nicotine withdrawal symptoms, and so allows ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199244030-00011

    authors: Palmer KJ,Buckley MM,Faulds D

    更新日期:1992-09-01 00:00:00

  • 5-HT3 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting. A comparison of their pharmacology and clinical efficacy.

    abstract::In the mid-1980s it was discovered that serotonin (5-hydroxytryptamine; 5-HT) was at least partially responsible for producing chemotherapy-induced nausea and vomiting. It was therefore realised that serotonin receptor blockade with serotonin 5-HT3 receptor antagonists could inhibit chemotherapy-induced nausea and vom...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199855020-00002

    authors: Gregory RE,Ettinger DS

    更新日期:1998-02-01 00:00:00

  • Influence of fibrinogen on cardiovascular disease.

    abstract::Results from prevalence, case-control, angiographic and echocardiographic investigations incriminate elevated fibrinogen levels as a strong independent risk factor for the occurrence of initial and recurrent cardiovascular events. Average fibrinogen levels are higher in women and persons with other risk factors includ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199700543-00006

    authors: Kannel WB

    更新日期:1997-01-01 00:00:00

  • Reduction of prostaglandin E2 concentrations in synovial fluid of patients suffering from rheumatoid arthritis following tiaprofenic acid or indomethacin treatment.

    abstract::Prostaglandin E2 (PGE2) is a potent stimulator of inflammation, and the inhibition of its synthesis is one possible mechanism of action of non-steroidal anti-inflammatory drugs (NSAIDs). We have investigated patients suffering from rheumatoid arthritis to determine how synovial fluid levels of PGE2 are affected by tia...

    journal_title:Drugs

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2165/00003495-198800351-00004

    authors: Daymond TJ,Rowell FJ

    更新日期:1988-01-01 00:00:00

  • Olaratumab: First Global Approval.

    abstract::Olaratumab (Lartruvo™) is a fully human IgG1 monoclonal antibody targeted against the human platelet-derived growth factor (PDGF) receptor α (PDGFRα). It was developed by Eli Lilly and Co. (previously ImClone Systems) after PDGFRα was identified as a potential therapeutic target in a variety of cancers. Olaratumab act...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-016-0680-2

    authors: Shirley M

    更新日期:2017-01-01 00:00:00

  • Parenteral cephalosporin therapy in ambulatory care: advantages and disadvantages.

    abstract::Outpatient parenteral antibiotic therapy (OPAT) programmes are effective, well tolerated and economically advantageous in carefully selected patient populations. Inclusion criteria for patient selection for OPAT include good clinical appearance and uncomplicated infection. By virtue of their favourable microbiological...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200059003-00003

    authors: Esposito S

    更新日期:2000-01-01 00:00:00

  • Long-term growth hormone replacement therapy in hypopituitary adults.

    abstract::Growth hormone deficiency (GHD) in the adult has now been fully recognised as a clinical entity characterised by abnormal body composition, osteopenia, impaired quality of life, cardiac dysfunction and an adverse lipid profile. While short-term studies of GH replacement have demonstrated irrefutably a favourable effec...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200262160-00006

    authors: Verhelst J,Abs R

    更新日期:2002-01-01 00:00:00

  • Assessment of the risk-benefit ratio for antiarrhythmic drug use.

    abstract::Arrhythmia treatment has always been difficult, particularly as there are no good indicators of the optimal management strategy. The introduction of new antiarrhythmic agents has forced reappraisal of how these drugs are used. Dynamic electrocardiography and invasive electrophysiological studies are important tools fo...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-198836050-00005

    authors: Campbell RW

    更新日期:1988-11-01 00:00:00

  • Acute viral infections of the central nervous system in immunocompetent adults: diagnosis and management.

    abstract::Patients with viral infections of the central nervous system (CNS) may present with a variety of neurological symptoms, most commonly dominated by either encephalitis or meningitis. The aetiological panorama varies in different parts of the world as well as over time. Thus, virological first-line diagnostics must be a...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-013-0007-5

    authors: Studahl M,Lindquist L,Eriksson BM,Günther G,Bengner M,Franzen-Röhl E,Fohlman J,Bergström T,Aurelius E

    更新日期:2013-02-01 00:00:00

  • Value of non-drug treatment and drug treatment in hypertension.

    abstract::The benefits of the treatment of hypertension currently consist of a substantially reduced incidence of premature stroke, left ventricular failure and malignant hypertension. The benefits for the individual are most clearcut in those who have already had severe or symptomatic hypertension. Older subjects who have a hi...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-198800366-00003

    authors: Beilin LJ

    更新日期:1988-01-01 00:00:00

  • Sitagliptin: a review of its use in patients with type 2 diabetes mellitus.

    abstract::Sitagliptin (Januvia(®), Xelevia™, Glactiv(®), Tesavel(®)) is an orally administered, potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and was the first agent of its class to be approved for use in the management of adults with type 2 diabetes. Numerous randomized placebo- or active comparator-c...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-013-0169-1

    authors: Plosker GL

    更新日期:2014-02-01 00:00:00

  • HIV-1 antiretroviral resistance: scientific principles and clinical applications.

    abstract::The efficacy of an antiretroviral (ARV) treatment regimen depends on the activity of the regimen's individual ARV drugs and the number of HIV-1 mutations required for the development of resistance to each ARV - the genetic barrier to resistance. ARV resistance impairs the response to therapy in patients with transmitt...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11633630-000000000-00000

    authors: Tang MW,Shafer RW

    更新日期:2012-06-18 00:00:00

  • Antibacterials as adjuncts to incision and drainage for adults with purulent methicillin-resistant Staphylococcus aureus (MRSA) skin infections.

    abstract::The annual incidence of skin and soft tissue infections (SSTIs) has nearly tripled in the US since the early 1990s. Many purulent SSTIs in the community setting are caused by methicillin-resistant Staphylococcus aureus (MRSA). Incision and drainage (I&D) are indicated for most purulent MRSA infections; however, the us...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11599510-000000000-00000

    authors: Forcade NA,Wiederhold NP,Ryan L,Talbert RL,Frei CR

    更新日期:2012-02-12 00:00:00

  • The memory clinic. A new approach to the detection of early dementia.

    abstract::Dementia is commonly diagnosed at a time of major domestic breakdown, when symptoms are severe and family and community patience has been eroded. In order to encourage early referral and identification of patients with treatable conditions, a Memory Clinic is held at the University Hospital in Cardiff. The clinic prov...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-198700332-00016

    authors: Bayer AJ,Pathy MS,Twining C

    更新日期:1987-01-01 00:00:00

  • Irinotecan. A review of its pharmacological properties and clinical efficacy in the management of advanced colorectal cancer.

    abstract::Irinotecan (CPT-II) is a semisynthetic derivative of camptothecin. It and other camptothecin analogues/derivatives appear to exert their antitumour activity by binding to topoisomerase I. The active metabolite of irinotecan, 7-ethyl-10-hydroxycamptothecin (SN-38), has demonstrated potent growth inhibition of human col...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199652040-00013

    authors: Wiseman LR,Markham A

    更新日期:1996-10-01 00:00:00

  • Crizotinib: a review of its use in the treatment of anaplastic lymphoma kinase-positive, advanced non-small cell lung cancer.

    abstract::Crizotinib (Xalkori(®)) is an orally active, small molecule inhibitor of multiple receptor tyrosine kinases, including anaplastic lymphoma kinase (ALK), c-Met/hepatocyte growth factor receptor and c-ros oncogene 1. In the EU, crizotinib has been conditionally approved for the treatment of adults with previously treate...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-013-0142-z

    authors: Frampton JE

    更新日期:2013-12-01 00:00:00