Drugs

Cummings, Jeffrey

doi: 10.1007/s40265-023-01858-9pmid: 37060386

Two anti-amyloid monoclonal antibodies (MABs)—lecanemab (Leqembi®) and aducanumab (Aduhelm®)—have been approved in the USA for the treatment of Alzheimer's disease (AD). Anti-amyloid monoclonal antibodies are the first disease-modifying therapies for AD that achieve slowing of clinical decline by intervening in the basic biological processes of the disease. These are breakthrough agents that can slow the inevitable progression of AD into more severe cognitive impairment. The results of trials of anti-amyloid MABs support the amyloid hypothesis and amyloid as a target for AD drug development. The success of MABs reflects a relentless application of neuroscience knowledge to solving major challenges facing humankind. The success of these transformative agents will foster the development of more anti-amyloid MABs, other types of anti-amyloid therapies, treatments of other targets of AD biology, and new approaches to therapies for an array of neurodegenerative disorders. Monoclonal antibodies have side effects and, during the period of treatment initiation, patients must be closely monitored for the occurrence of amyloid-related imaging abnormalities (ARIA) and infusion reactions. A successful first step in the development of disease-modifying therapy for AD defines desirable features for the next phase of therapeutic development including less frequent ARIA, more convenient administration, and greater efficacy. Unprecedented agents make new demands on patients and care partners, clinicians, payers, and health care systems. Collaboration among stakeholders is essential to take advantage of the therapeutic benefits offered by these agents and to make them widely available. Monoclonal antibodies usher in a new era in AD therapy and define a new landscape of what is possible for therapeutic development for neurodegenerative disorders.

Alamri, Ayedh K.; Ma, Christy L.; Ryan, John J.

doi: 10.1007/s40265-023-01862-zpmid: 37017914

Pulmonary arterial hypertension (PAH) is a progressive disease that despite advances in therapy is associated with a 7-year survival of approximately 50%. Several risk factors are associated with developing PAH, include methamphetamine use, scleroderma, human immunodeficiency virus, portal hypertension, and genetic predisposition. PAH can also be idiopathic. There are traditional pathways underlying the pathophysiology of PAH involving nitric oxide, prostacyclin, thromboxane A2, and endothelin-1, resulting in impaired vasodilation, enhanced vasoconstriction and proliferation in the pulmonary vasculature. Established PAH medications targets these pathways; however, this paper aims to discuss novel drugs for treating PAH by targeting new and alternative pathways.

Pan, Bei; Ge, Long; Lai, Honghao; Hou, Liangying; Tian, Chen; Wang, Qi; Yang, Kelu; Lu, Yao; Zhu, Hongfei; Li, Mengting; Wang, Deren; Li, Xiuxia; Zhang, Yuqing; Gao, Ya; Liu, Ming; Ding, Guowu; Tian, Jinhui;

Chen, Thomas Yen-Ting; Wang, Shiow-Ing; Hung, Yao-Min; Hartman, Joshua J.; Chang, Renin; Wei, James Cheng-Chung

doi: 10.1007/s40265-023-01867-8pmid: 37162705

ObjectiveTo explore the association between human papillomavirus (HPV) vaccination and risk of coronavirus disease 2019 (COVID-19). Specifically, our study aimed to test the hypothesis that HPV vaccination may also induce trained immunity, which would potentially reduce the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and improve clinical outcomes.BackgroundSeveral vaccines have been reported to trigger non-specific immune reactions that could offer protection from heterologous infections. A recent case report showed that verruca vulgaris regressed after COVID-19, suggesting a possible negative association between COVID‐19 and HPV infection.MethodsWe enrolled 57,584 women with HPV vaccination and compared them with propensity score-matched controls who never received HPV vaccination in relation to the risk of COVID‐19 incidence. Cox proportional hazard regression analysis was conducted to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Subgroup analyses stratified by age, race, comorbid asthma, and obesity were performed.ResultsThe risk of COVID-19 incidence was significantly lower in those who had recently received the HPV vaccine (within 1 year after HPV vaccination, aHR: 0.818, 95% CI 0.764–0.876; within 1–2 years after HPV vaccination, aHR: 0.890, 95% CI 0.824–0.961). Several limitations were recognized in this study, including residual confounding, problems of misclassification due to the use of electronic health record data, and that we were unable to keep track of the patients' HPV infection status and the HPV antibody levels in those who had received the vaccine.ConclusionsRecent HPV vaccination was associated with a lower risk of incident COVID-19 and hospitalization. Based on the promising protective effect of HPV vaccine shown in this study, these findings should be replicated in an independent dataset. Further studies are needed to provide a better understanding of the underlying mechanisms and the differences in risks among 2-, 4-, or 9-valent HPV vaccine recipients.

Keam, Susan J.

doi: 10.1007/s40265-023-01866-9pmid: 37022666

Efanesoctocog alfa (ALTUVIIIOTM; [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]), a von Willebrand factor (VWF) independent, recombinant DNA-derived Factor VIII (FVIII) concentrate, has been developed by Bioverativ Therapeutics, Inc (a Sanofi company) and Swedish Orphan Biovitrum AB (Sobi). Efanesoctocog alfa was approved in February 2023 in the USA for use in adults and children with hemophilia A (congenital FVIII deficiency) for: routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; perioperative management of bleeding. This article summarizes the milestones in the development of efanesoctocog alfa leading to this first approval for hemophilia A.

Kang, Connie

doi: 10.1007/s40265-023-01865-wpmid: 37074491

Keverprazan hydrochloride (凯普拉生) is a potassium ion competitive acid blocker that is being developed by Jiangsu Carephar Pharmaceuticals for the treatment of acid-related disease. Keverprazan hydrochloride was recently approved in China for the treatment of adults with reflux oesophagitis or duodenal ulcer. This article summarizes the milestones in the development of keverprazan hydrochloride leading to this first approval for reflux oesophagitis and duodenal ulcer.

Kow, Chia Siang; Ramachandram, Dinesh Sangarran; Hasan, Syed Shahzad

doi: 10.1007/s40265-023-01869-6pmid: N/A

Plocque, Alexia; Philippart, Francois

doi: 10.1007/s40265-023-01870-zpmid: N/A