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

Download Mobile App





Merck and Ridgeback’s Oral COVID-19 Antiviral Medicine Receives First Authorization in the World

By HospiMedica International staff writers
Posted on 05 Nov 2021
Print article
Illustration
Illustration

Merck (Kenilworth, NJ, USA) and Ridgeback Biotherapeutics (Miami, FL, USA) have received authorization in the UK for their antiviral molnupiravir for the treatment of COVID-19.

With this, molnupiravir has become the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The authorization is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, 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 the UK, LAGEVRIO is the planned trademark for molnupiravir while the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world.

“The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert M. Davis, chief executive officer and president, Merck.

“As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the COVID-19 pandemic,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories. “We are very grateful to the investigators, patients and their families for their critical contributions to the MOVe-OUT study that made this authorization possible.”

“When we embarked on the journey to take molnupiravir from a hope to a reality, we believed we had a responsibility to move as quickly and safely as possible. We believed each day saved could save lives and limit severe disease and the global hardships of this pandemic,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “It is gratifying to reach this milestone and show that the extraordinary effort of our collaborators, patients, physicians and team and the personal sacrifices made have now achieved that important goal. It is also gratifying to see the first global authorization occur in the UK, the very place where we administered molnupiravir to the first brave human volunteer.”

Related Links:
Merck
Ridgeback Biotherapeutics 


Print article
IIR Middle East

Channels

Critical Care

view channel
Image: Three dimensional measurement of the all-mesh thermistor (Photo courtesy of Shinshu University)

Ultraflexible, Gas-Permeable Thermistors to Pave Way for On-Skin Medical Sensors and Implantable Devices

On-skin medical sensors and wearable health devices are important health care tools that must be incredibly flexible and ultrathin so they can move with the human body. In addition, the technology has... Read more

Surgical Techniques

view channel
Image: The POINT Kinguide robotic-assisted surgical system has made its debut in the US (Photo courtesy of Point Robotics)

First-Ever Spinal Surgical Hand-Held Robot Makes Worldwide Debut

The world’s first ever hand-held robot framework equipped with a parallel manipulator for orthopedic application has made its worldwide debut in the U.S. Point Robotics MedTech Inc. (Taipei, Taiwan) has... Read more

Patient Care

view channel
Image: The biomolecular film can be picked up with tweezers and placed onto a wound (Photo courtesy of TUM)

Biomolecular Wound Healing Film Adheres to Sensitive Tissue and Releases Active Ingredients

Conventional bandages may be very effective for treating smaller skin abrasions, but things get more difficult when it comes to soft-tissue injuries such as on the tongue or on sensitive surfaces like... 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
Copyright © 2000-2022 Globetech Media. All rights reserved.