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October 12, 2021

Merck seeks EUA for molnupiravir to treat Covid-19 in the US

The EUA application for molnupiravir is based on positive results obtained from the Phase III MOVe-OUT clinical trial.

Merck has submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) for its investigational oral antiviral medicine, molnupiravir (MK-4482/EIDD-2801), to treat Covid-19.

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Being developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an investigational, orally-administered potent ribonucleoside analogue that can prevent the SARS-CoV-2 virus replication.

The company is seeking the FDA authorisation for its antiviral medicine to treat adult patients with mild-to-moderate Covid-19 who are at risk of progressing to severity or hospitalisation.

The EUA submission is based on the positive results obtained from the Phase III MOVe-OUT clinical trial, which were announced earlier this month.

This Phase III part of the trial was conducted in more than 170 planned clinical trial sites worldwide including Sweden, Chile, Guatemala, Poland, Taiwan, Argentina, Brazil, Canada, Colombia, Egypt, France, Germany, Israel, Italy, Japan, Mexico, Philippines, Russia, South Africa, Spain, Ukraine, the UK and the US.

The interim analysis showed that molnupiravir lowered hospitalisation or death risk by nearly 50% and nearly 7.3% were in hospital or died by day 29 compared to 14.1% of patients treated with placebo.

Ridgeback Biotherapeutics CEO Wendy Holman said: “The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with Covid-19.

“We are pleased to partner with Merck and regulatory authorities to help provide molnupiravir to the people who need it here in the US and around the world.”

Furthermore, the companies are working to submit applications for emergency use or marketing authorisation of molnupiravir with regulatory agencies across the world in the coming months.

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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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