1 / 3

A New Generation Of Antiviral Drug Baloxavir Marboxil's Brief Introduction And Clinical Results

The antiviral drug, Baloxavir marboxil (tradename Xofluza), is the first treatment for influenza with a new mode of "action" to be licensed in nearly 20 years. It was approved in Australia in February 2020 by the Therapeutic Goods Administration (TGA) and has been used to treat influenza in Japan, the USA, and several other countries since 2018.

sunnyfang1419
Download Presentation

A New Generation Of Antiviral Drug Baloxavir Marboxil's Brief Introduction And Clinical Results

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Huateng Pharma https://en.huatengsci.com/ A New Generation Of Antiviral Drug Baloxavir Marboxil's Brief Introduction And Clinical Results Influenza is an acute respiratory infectious disease caused by pandemic influenza virus, which is mainly spread through contact and air droplets, and is common in winter and summer. In April 2020, the DEPARTMENT OF DISEASES CONTROL, MOH released an overview of the epidemic situation of statutory infectious diseases in China in 2019. Among them, the number of reported flu cases ranked first, reaching 3.5 million cases, with an incidence rate of 253/10 million, an increase of 359% from last year and showing an obvious increase. The antiviral drug, Baloxavir marboxil (tradename Xofluza), is the first treatment for influenza with a new mode of "action" to be licensed in nearly 20 years. It was approved in Australia in February 2020 by the Therapeutic Goods Administration (TGA) and has been used to treat influenza in Japan, the USA, and several other countries since 2018. Mode of action of BXM in infected cells Image from: https://www.researchgate.net Baloxavir marboxil had global sales of $245 million in 2018. Compared with oseltamivir, Baloxavir Marboxil doesn't require a course of treatment

  2. Huateng Pharma https://en.huatengsci.com/ (oseltamivir requires continuous treatment for 5 days), it is administered only once a day. The disease symptom remission time of Baloxavir marboxil was non-inferior, virus titer and safety were superior to oseltamivir. This may break the pattern of neuraminidase inhibitors dominating the influenza market in the past 20 years and provide a new treatment mechanism for influenza, which has been widely concerned by the industry. Baloxavir marboxil developed two dosage forms, tablets and granules. In March 2018, Baloxavir marboxil tablets was approved for the first time in Japan for the treatment of acute uncomplicated influenza patients aged 12 and over, and its granules was approved in Japan in September of the same year. Baloxavir marboxil was approved for sale by the FDA in December 2018. In October 2019, the FDA approved it for the treatment of people over 12 years of age who are at high risk for influenza complications. In March 2020, Roche submitted to FDA an application for the marketing of tablets and granules for influenza prevention over the age of 1 and for the treatment of acute complications of influenza under the age of 12. On June 10, 2020, the application for marketing of Baloxavir marboxil tablets submitted by Roche in China was accepted by NMPA. The Phase III clinica (CAPSTONE-1) study was a randomized, double-blind, controlled trial that enrolling patients aged 12-64 years who were diagnosed with influenza and had flu symptoms did not exceed 48 hours. Patients aged 20-64 were randomly divided into groups according to the 2:2:1 ratio, and were given Baloxavir marboxil once a day(40 mg for patients under 80 kg and 80 mg for patients above 80 kg), oseltamivir (75 mg twice a day) and placebo for five consecutive days. Patients aged 12-19 were given Baloxavir marboxil and placebo at 2:1. Clinical results showed that Baloxavir Marboxil had a shorter duration of fever (24.5h) than placebo (42.0h), and the duration of symptom relief was similar to oseltamivir (53.5h vs. 53.8h). In addition, the virus reduction was greater than placebo and oseltamivir. Baloxavir marboxil, oseltamivir, and placebo reduced by 4.4, 2.5, and 1.2 log10TCID50, respectively, from baseline after 24h of treatment. Baloxavir marboxil significantly reduced the time to stop virus release (24h) compared with placebo (96h) and oseltamivir (72h). In terms of safety, the overall incidence of adverse events in Baloxavir Marboxil (20.7%) was lower than placebo (24.6%) and oseltamivir (24.8%), and the incidence of common drug-related adverse events was lower than oseltamivir (8.4%) and equivalent to placebo (4.4% vs. 3.9%). The common adverse events of Baloxavir Marboxil were diarrhea (3.0%), bronchitis (2.6%), nasopharyngitis (1.5%), nausea (1.3%), sinusitis (1.1%) and elevated ALT (1.0%) . Therefore, Baloxavir Marboxil has a significant advantage in both

  3. Huateng Pharma https://en.huatengsci.com/ efficacy and safety. The Capstone-2 clinical trial was also a randomized, double-blind, controlled trial that recruited people over 12 years of age who were at high risk for influenza complications. Clinical results revealed that Baloxavir Marboxil improved symptoms for a shorter time (73h) than placebo (102h), with no significant difference from oseltamivir (81.0h).Baloxavir marboxil significantly reduced the time to stop virus release, with a median time of 48h, oseltamivir and placebo of 96h, significantly reducing the incidence of flu-related complications by 2.8%, oseltamivir 4.6%, and placebo 10.4% In addition, Baloxavir Marboxil was approved by the FDA in October 2019 based on the results of the Phase III clinical (CAPSTONE-2) trial for the treatment of people at high risk of influenza complications over the age of 12 years, which is the first antiviral drug to show clinically significant benefit in a population at high risk for influenza complications. The CAPSTONE-2 clinical trial was also a randomized, double-blind, controlled trial, enrolling people at high risk of influenza complications over the age of 12. Clinical results revealed that Baloxavir Marboxil improved symptoms (73h) shorter than the placebo (102h), with no significant difference from oseltamivir (81.0h). Baloxavir marboxil significantly shorten the time to stop virus release, with a median time of 48h, and 96h for oseltamivir and placebo. It also significantly reduce the incidence of influenza-related complications (Baloxavir marboxil 2.8%, oseltamivir 4.6%, placebo 10.4%). Huateng Pharma is committed to providing cost-effective pharmaceutical products and services to customers around the world with the belief of “Strive for the Human Health". We supply a variety of anti-viral pharmaceutical intermediates used in research and development, such as Remdesivir intermediates, Favipiravir intermediates, Baloxavir Marboxil intermediates, Oseltamivir intermediates and so on. Baloxavir Marboxil intermediates: CAS NO.2136287-68-6, CAS NO.1985607-70-2, CAS NO.2136287-66-4 and CAS NO.1985607-83-7. Related articles: 1. Baloxavir Marboxil for Uncomplicated Influenza: Mechanism of Action & Side Effects 2. Pharmaceutical Intermediates of Carfilzomib & Baloxavir Marboxil 3. An Effective Anti-influenza Drug: Oseltamivir (Tamiflu)

More Related