Merck pill seen as ‘huge breakthrough’ raises hopes of preventing COVID-19 deaths

  • Merck will seek US approval for the pill as soon as possible
  • If approved, it would be the first oral antiviral drug COVID-19
  • Merck shares rally, some vaccine makers drop
  • US government to buy 1.7 million courses at $ 700 each

Oct 1 (Reuters) – An experimental antiviral pill developed by Merck & Co (MRK.N) could halve the risk of death or hospitalization for those most at risk of severe COVID-19, data shows which experts have hailed as a potential breakthrough in the way the virus is treated.

If approved, molnupiravir, which is designed to introduce errors into the virus’s genetic code, would be the first oral antiviral drug for COVID-19.

Merck and its partner Ridgeback Biotherapeutics said they plan to apply for emergency use authorization in the United States for the pill as soon as possible and to file regulatory applications worldwide.

“An oral antiviral that can have such an impact on the risk of hospitalization would be a game-changer,” said Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Security.

Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir (GILD.O) and the generic steroid dexamethasone, which are usually only given after a patient has already been hospitalized.

“This will change the dialogue on how to deal with COVID-19,” Merck chief executive Robert Davis told Reuters.

Existing treatments are “logistically heavy and difficult to administer. A simple oral pill would be the opposite of that,” Adalja added.

The results of the Phase III trial, which boosted Merck’s shares by more than 9%, were so strong that the study was terminated prematurely on the recommendation of external monitors.

Shares of Atea Pharmaceuticals Inc (AVIR.O), which is developing a similar COVID-19 treatment, rose more than 21% on the news.

Shares of COVID-19 vaccine makers Moderna Inc (MRNA.O) were down more than 10%, while Pfizer (PFE.N) was down less than 1%.

Jefferies analyst Michael Yee said investors believe “people will be less afraid of COVID and less likely to get vaccinated if there is a simple pill that can treat COVID.”

Pfizer and Swiss drug maker Roche Holding AG (ROG.S) are also fighting to develop an easy-to-administer antiviral pill for COVID-19. At this time, only antibody cocktails that must be administered intravenously are permitted for outpatients.

White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is “a potential additional tool … to protect people from the worst consequences of COVID”, but added that vaccination “remains a long way off , our best tool against COVID-19 19. “

A planned interim analysis of 775 patients in the Merck study looked at hospitalizations or deaths among those at risk for serious illness. It found that 7.3% of people who received molnupiravir twice a day for five days were hospitalized and none died 29 days after treatment. This compares to a hospitalization rate of 14.1% for patients on placebo. There were also eight deaths in the placebo group.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of hospital are badly needed,” Ridgeback CEO Wendy Holman said in a statement.

An experimental COVID-19 treatment pill called molnupiravir under development by Merck & Co Inc and Ridgeback Biotherapeutics LP, can be seen in this undated photo released by Merck & Co Inc and obtained by Reuters on May 17, 2021. Merck & Co Inc / Handout via REUTERS

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Scientists hailed the potential new treatment to help prevent serious illnesses caused by the virus, which has killed nearly 5 million people worldwide, including 700,000 in the United States.

“A safe, affordable and effective oral antiviral would be a huge step forward in the fight against COVID,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

The study recruited patients with laboratory-confirmed mild to moderate COVID-19 who had symptoms for up to five days. All patients had at least one risk factor associated with poor disease progression, such as obesity or advanced age.

Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck said similar studies with molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.

Merck said viral sequencing done so far shows molnupiravir to be effective against all variants of the coronavirus, including the highly transmissible Delta, which has led to the recent global increase in hospitalizations and deaths.

He said the rates of adverse events were similar for patients on molnupiravir and placebo, but did not give details.

Merck said data shows molnupiravir is not able to induce genetic changes in human cells, but men in its trials had to refrain from heterosexual sex or agree to use contraception. Women of childbearing potential in the study could be pregnant and also had to use contraception.

The US drug maker has said it plans to produce 10 million treatments by the end of 2021.

The company has a contract with the US government to provide 1.7 million courses of molnupiravir at a cost of $ 700 per course.

Davis said Merck has similar agreements with other governments and is in talks with others. Merck said it plans a tiered pricing approach based on the country’s income criteria.

The US government has the option to purchase up to 3.5 million additional treatments if needed, a US health official told Reuters. The official asked to remain anonymous as he was not authorized to comment publicly on the contract.

Merck also agreed to license the drug to several generic drug manufacturers based in India, who would be able to provide the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a phase III trial to prevent infection in people exposed to the coronavirus.

Merck officials said it was not clear how long the FDA review would last, although Dean Li, head of Merck’s research labs, said, “They’ll try to work with it. eagerness on this subject “.

Reporting by Deena Beasley and Carl O’Donnell; Additional reports by Joséphine Mason and Ahmed Aboulenein; Editing by Lincoln Feast, Kirsten Donovan, Alexander Smith, Bill Berkrot and Sonya Hepinstall

Our Standards: The Thomson Reuters Trust Principles.

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