DrugsPub Date : 2024-09-01Epub Date: 2024-09-06DOI: 10.1007/s40265-024-02088-3
Hannah A Blair
{"title":"Correction: Elafibranor: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-024-02088-3","DOIUrl":"10.1007/s40265-024-02088-3","url":null,"abstract":"","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1165"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-20DOI: 10.1007/s40265-024-02080-x
Susan J Keam
{"title":"Imetelstat: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-024-02080-x","DOIUrl":"10.1007/s40265-024-02080-x","url":null,"abstract":"<p><p>Imetelstat (RYTELO™), an oligonucleotide telomerase inhibitor, is being developed by Geron Corporation for the treatment of myeloid hematologic malignancies. In June 2024, imetelstat was approved in the USA for use in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). This article summarizes the milestones in the development of imetelstat leading to this first approval for the treatment of adult patients with low- to intermediate-1 risk MDS with transfusion-dependent anemia.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1149-1155"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-21DOI: 10.1007/s40265-024-02083-8
Benjamin J Cowling, George N Okoli
{"title":"Influenza Vaccine Effectiveness and Progress Towards a Universal Influenza Vaccine.","authors":"Benjamin J Cowling, George N Okoli","doi":"10.1007/s40265-024-02083-8","DOIUrl":"10.1007/s40265-024-02083-8","url":null,"abstract":"<p><p>At various times in recent decades, surges have occurred in optimism about the potential for universal influenza vaccines that provide strong, broad, and long-lasting protection and could substantially reduce the disease burden associated with seasonal influenza epidemics as well as the threat posed by pandemic influenza. Each year more than 500 million doses of seasonal influenza vaccine are administered around the world, with most doses being egg-grown inactivated subunit or split-virion vaccines. These vaccines tend to have moderate effectiveness against medically attended influenza for influenza A(H1N1) and influenza B, and somewhat lower for influenza A(H3N2) where differences between vaccine strains and circulating strains can occur more frequently due to antigenic drift and egg adaptations in the vaccine strains. Several enhanced influenza vaccine platforms have been developed including cell-grown antigen, the inclusion of adjuvants, or higher antigen doses, to improve immunogenicity and protection. During the COVID-19 pandemic there was unprecedented speed in development and roll-out of relatively new vaccine platforms, including mRNA vaccines and viral vector vaccines. These new platforms present opportunities to improve protection for influenza beyond existing products. Other approaches continue to be explored. Incremental improvements in influenza vaccine performance should be achievable in the short to medium term.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1013-1023"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11438668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-07-29DOI: 10.1007/s40265-024-02073-w
Sohita Dhillon
{"title":"Ivonescimab: First Approval.","authors":"Sohita Dhillon","doi":"10.1007/s40265-024-02073-w","DOIUrl":"10.1007/s40265-024-02073-w","url":null,"abstract":"<p><p>Ivonescimab (<sup>®</sup>) is a first-in-class, humanized, tetravalent bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF)-A being developed by Akeso Biopharma for the treatment of non-small cell lung cancer (NSCLC) and other solid tumours, including breast cancer, liver cancer and gastric cancer. Ivonescimab simultaneously blocks the binding of PD-1 to its ligand (PD-L1), thereby relieving PD-1/PD-L1-mediated immunosuppression, and blocks the binding of VEGF-A to its receptor (VEGFR2), thus blocking tumour angiogenesis in the tumour microenvironment. In May 2024, ivonescimab, in combination with pemetrexed and carboplatin, received its first approval in China for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after tyrosine kinase inhibitor (TKI) therapy. Clinical studies of ivonescimab are underway in multiple countries worldwide. This article summarizes the milestones in the development of ivonescimab leading to this first approval for EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1135-1142"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-28DOI: 10.1007/s40265-024-02081-w
Susan J Keam
{"title":"Ensifentrine: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-024-02081-w","DOIUrl":"10.1007/s40265-024-02081-w","url":null,"abstract":"<p><p>Ensifentrine, an inhaled, selective phosphodiesterase (PDE) 3 and PDE4 inhibitor, is being developed by Verona Pharma plc for the treatment of respiratory diseases, including chronic obstructive pulmonary disease (COPD). In June 2024, ensifentrine (OHTUVAYRE™) inhalation suspension was approved for the maintenance treatment of COPD in adult patients in the USA. This article summarizes the milestones in the development of ensifentrine leading to this first approval for the maintenance treatment of COPD.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1157-1163"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142079631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-01DOI: 10.1007/s40265-024-02062-z
Aaron Tisack, Tasneem F Mohammad
{"title":"Drug-Induced Pigmentation: A Review.","authors":"Aaron Tisack, Tasneem F Mohammad","doi":"10.1007/s40265-024-02062-z","DOIUrl":"10.1007/s40265-024-02062-z","url":null,"abstract":"<p><p>Drug-induced pigmentation (DIP) is estimated to account for 20% of all cases of acquired hyperpigmentation. Over 50 agents have been implicated, including antibiotics, antimalarials, antiretrovirals, antipsychotics, prostaglandin analogs, heavy metals, and chemotherapeutic agents. The skin, mucosal surfaces, nails, and hair can all be affected, with the color, distribution, onset, and duration of pigmentation varying between offending agents. Both a thorough physical examination and medication history are necessary to determine the offending agent. In terms of mechanism, DIP occurs most frequently through the accumulation of melanin within the dermis but also by drug accumulation, pigment synthesis, and iron deposition. Photoprotection, including applying a broad-spectrum sunscreen, wearing photoprotective clothing, and seeking shade, plays an important role in the prevention of exacerbation of DIP. Multiple lasers, including the picosecond alexandrite, Q-switched Nd:YAG, Q-switched alexandrite, and Q-switched ruby lasers, have been successful in obtaining clearance of DIP. In this review, we examine the unique characteristics of each of the inciting agents in terms of incidence, clinical presentation, time to onset and resolution, and pathogenesis.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1071-1091"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-07-26DOI: 10.1007/s40265-024-02071-y
Louise Kostos, Ben Tran, Arun A Azad
{"title":"Combination of PARP Inhibitors and Androgen Receptor Pathway Inhibitors in Metastatic Castration-Resistant Prostate Cancer.","authors":"Louise Kostos, Ben Tran, Arun A Azad","doi":"10.1007/s40265-024-02071-y","DOIUrl":"10.1007/s40265-024-02071-y","url":null,"abstract":"<p><p>Despite recent advances in the treatment of metastatic prostate cancer, progression to a castration-resistant state remains inevitable for most and prognosis is limited. Genetic testing for homologous recombination repair pathway alterations is recommended for all patients with advanced prostate cancer given that a mutation is present in up to 25% of cases. Poly(ADP-ribose) polymerase (PARPis) are now approved for use in patients with metastatic castration-resistant prostate cancer who have progressed on an androgen receptor pathway inhibitor (ARPI) and harbour a germline or somatic homologous recombination repair mutation. Preclinical data support a synergistic effect with an ARPI and PARPi, and various ARPI-PARPi combinations have therefore been explored in phase III clinical trials. Despite heterogeneous findings, a clear hierarchy of benefit is evident, with patients harbouring a BRCA mutation deriving the greatest magnitude of benefit, followed by any homologous recombination repair mutation. The benefit in homologous recombination repair-proficient cohort is less clear, and questions remain about whether ARPI-PARPi combination therapy should be offered to patients without a homologous recombination repair mutation. With ARPIs now considered standard-of-care for metastatic hormone-sensitive prostate cancer, ARPI-PARPi combination therapy is currently being explored earlier in the treatment paradigm. The purpose of this review is to discuss the rationale behind ARPI-PARPi combination therapy, summarise the results of key clinical trials, and discuss clinical considerations and future perspectives.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1093-1109"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11438617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141765779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-07-29DOI: 10.1007/s40265-024-02049-w
Mattia Galli, Giovanni Occhipinti, Luis Ortega-Paz, Francesco Franchi, Fabiana Rollini, Salvatore Brugaletta, Davide Capodanno, Sebastiano Sciarretta, Dominick J Angiolillo
{"title":"Therapeutic Potential of FXI Inhibitors: Hype or Hope?","authors":"Mattia Galli, Giovanni Occhipinti, Luis Ortega-Paz, Francesco Franchi, Fabiana Rollini, Salvatore Brugaletta, Davide Capodanno, Sebastiano Sciarretta, Dominick J Angiolillo","doi":"10.1007/s40265-024-02049-w","DOIUrl":"10.1007/s40265-024-02049-w","url":null,"abstract":"<p><p>Significant advancements have shaped the landscape of anticoagulant therapy in the past two decades, including the introduction of direct oral anticoagulants (DOACs), characterized by favorable safety and efficacy profiles and reduced drug-to-drug or food interaction resulting in excellent patient compliance. However, residual concerns still exist with standard-of-care anticoagulant therapy, including the inability to use DOACs in several clinical settings and the need to further reduce the risk of bleeding. Recent improvements in the understanding of the mechanisms behind thrombus formation have led to the awareness that the intrinsic pathway of the coagulation cascade may play an important role in pathological thrombosis, but not in hemostasis. This has represented the rationale for targeting this pathway with factor XI (FXI) inhibitors, with the aim of uncoupling hemostasis and thrombosis. Clinical evidence from patients with FXI deficiency further supports this concept. A number of compounds with different mechanisms of action have been developed to target FXI (i.e., asundexian, abelacimab, Ionis-FXIRx, milvexian, osocimab, and Xisomab 3G). To date, the majority of available trials have not gone beyond completion of phase 2 and results are conflictive making it difficult to appraise the clinical benefit of these compounds in the different clinical settings where they have been tested (i.e., atrial fibrillation, acute ischemic stroke, acute myocardial infarction, end-stage renal disease, total knee arthroplasty). Moreover, the largest phase 3 randomized trial designed to test the efficacy of asundexian over apixaban in patients with atrial fibrillation, the OCEANIC-AF, has been prematurely stopped as a result of the inferior efficacy of asundexian. In this review we discuss the pharmacological properties and available evidence generated thus far for factor XI inhibitors, providing a perspective on the current state of these drugs.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1055-1070"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-05DOI: 10.1007/s40265-024-02078-5
David Suphadetch Leungsuwan, Manju Chandran
{"title":"Bone Fragility in Diabetes and its Management: A Narrative Review.","authors":"David Suphadetch Leungsuwan, Manju Chandran","doi":"10.1007/s40265-024-02078-5","DOIUrl":"10.1007/s40265-024-02078-5","url":null,"abstract":"<p><p>Bone fragility is a serious yet under-recognised complication of diabetes mellitus (DM) that is associated with significant morbidity and mortality. Multiple complex pathophysiological mechanisms mediating bone fragility amongst DM patients have been proposed and identified. Fracture risk in both type 1 diabetes (T1D) and type 2 diabetes (T2D) continues to be understated and underestimated by conventional risk assessment tools, posing an additional challenge to the identification of at-risk patients who may benefit from earlier intervention or preventive strategies. Over the years, an increasing body of evidence has demonstrated the efficacy of osteo-pharmacological agents in managing skeletal fragility in DM. This review seeks to elaborate on the risk of bone fragility in DM, the underlying pathogenesis and skeletal alterations, the approach to fracture risk assessment in DM, management strategies and therapeutic options.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1111-1134"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DrugsPub Date : 2024-09-01Epub Date: 2024-08-07DOI: 10.1007/s40265-024-02075-8
Hannah A Blair
{"title":"Elafibranor: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-024-02075-8","DOIUrl":"10.1007/s40265-024-02075-8","url":null,"abstract":"<p><p>Elafibranor (IQIRVO<sup>®</sup>) is a first-in-class peroxisome proliferator-activated receptor (PPAR) agonist being developed by Ipsen, under license from Genfit, for the treatment of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). On 10 June 2024, elafibranor received accelerated approval based on reduction of alkaline phosphatase (ALP) in the USA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Elafibranor has also received a positive opinion in the EU. This article summarizes the milestones in the development of elafibranor leading to this first approval for PBC.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1143-1148"},"PeriodicalIF":13.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}