We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Detecto

Download Mobile App





Merck and Ridgeback’s Oral Antiviral Receives US FDA EUA for Treatment of COVID-19 in Certain Adults

By HospiMedica International staff writers
Posted on 24 Dec 2021
Print article
Illustration
Illustration

Merck (Kenilworth, NJ, USA) and Ridgeback Biotherapeutics (Miami, FL, USA) have been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801).

Molnupiravir has not been approved, but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is not authorized for use in patients who are less than 18 years of age, for initiation of treatment in patients hospitalized due to COVID-19, for use for longer than five consecutive days, or for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

The authorization is based on the Phase 3 MOVe-OUT trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized adult patients who were unvaccinated against SARS-CoV-2, had laboratory-confirmed SARS-CoV-2 infection, symptom onset within five days of study randomization, and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes). In analyses from all randomized patients, molnupiravir reduced the risk of hospitalization or death: 9.7% (68/699) of patients in the placebo group were hospitalized or died compared to 6.8% (48/709) of patients who received molnupiravir, for an absolute risk reduction of 3.0%. Nine deaths were reported in the placebo group, and one in the molnupiravir group.

“The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives. Because we recognized the promise of molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that molnupiravir, now authorized, can be available to patients here in the U.S. and all around the world more quickly and more equitably than has ever been accomplished before,” said Robert M. Davis, chief executive officer and president, Merck.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”

Related Links:
Merck
Ridgeback Biotherapeutics 

BMP Whole Blood Analyzer: GEM Premier ChemSTAT
Gold Supplier
Newborn Hemoglobin Screening System
VARIANTnbs
New
POC Glucose Meter
HemoCue Glucose 201 RT System
New
Medical Digital Video Recorder
IPS720

Print article

Channels

AI

view channel
Image: EchoGo Heart Failure is the first and only AI-enabled HFpEF detection platform for echocardiography (Photo courtesy of Ultromics)

AI Solution for Echocardiography to Revolutionize Diagnosis of Heart Failure with Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure often associated with co-morbidities and tends to be caused by increased pressure within the chambers of the heart.... Read more

Critical Care

view channel
Image: Lodestar DX provides lab-accurate test results in 30 minutes (Photo courtesy of Llusern Scientific)

Portable UTI Molecular Diagnostic Platform Provides Accurate Test Results in 40 Minutes

Despite being one of the most common types of infection Urinary Tract Infections (UTIs) are a comparatively neglected area of medicine. There are no highly accurate diagnostic tools available for point-of-care... Read more

Surgical Techniques

view channel
Image: ActivSight Intelligent Light has received CE Mark approval (Photo courtesy of Activ Surgical)

Enhanced Imaging System to Become a Game-Changer in the OR by Revolutionizing Surgical Vision

Critical structure identification and tissue perfusion assessment are essential for patients to have the best possible chance of healing well without facing life-threatening or costly complications.... Read more

Patient Care

view channel
Image: Automated cleaning system allows endoscopes to be cleaned direct from clinic (Photo courtesy of Aston University)

World’s First Automated Endoscope Cleaner Fights Antimicrobial Resistance

Endoscopes are long, thin tubes with a light and camera at one end. Due to the sensitivity of the materials and electronics they cannot be sterilized in an autoclave (a machine that uses steam under pressure),... Read more

Health IT

view channel
Image: Using digital data can improve health outcomes (Photo courtesy of Unsplash)

Electronic Health Records May Be Key to Improving Patient Care, Study Finds

When a patient gets transferred from a hospital to a nearby specialist or rehabilitation facility, it is often difficult for personnel at the new facility to access the patient’s electronic health records... Read more

Business

view channel
Image: The global multiparameter patient monitoring systems market is expected to surpass USD 15 billion by 2028 (Photo courtesy of Unsplash)

Global Multiparameter Patient Monitoring Systems Market Driven by Rising Chronic Illnesses

Multi-parameter patient monitoring equipment is used to assess the vital signs of patients who are suffering from a serious illness. These devices are meant to give the number of data sets on one screen... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.