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22 Jan 2022

MSD seeking authorisation for new oral Covid drug

MSD seeking authorisation for new oral Covid drug

MSD seeking authorisation for new oral Covid drug

Pharmaceutical company Merck Sharp and Dohme (MSD) has said it will seek authorisation in the US for an oral drug for Covid-19, after the pill showed "compelling results" in a clinical trial.

The experimental drug, molnupiravir, is designed to significantly reduced the risk of hospitalisation or death when administered to high-risk patients early in the disease.

In the trial, which enrolled patients around the world that had mild-to-moderate Covid, molnupiravir was taken every 12 hours for five days, with no deaths recorded.

All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

"Merck plans to seek emergency use authorisation in the US as soon as possible and to submit applications to regulatory agencies worldwide," the companies said.

If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for Covid-19.

"Antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed," said Wendy Holman, Ridgeback's CEO.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including highly transmissible Delta.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception and women of child-bearing age cannot be pregnant and also have to use birth control.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year with The company saying it has a US government contract to supply 1.7m courses of molnupiravir at a price of $700 per course.

"This is going to change the dialogue around how to manage Covid-19," said Robert Davis, Merck's chief executive officer.

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