Covid-19’s Tamiflu Pill Succeeds in Key Study – .

Covid-19’s Tamiflu Pill Succeeds in Key Study – .

The pill reduced the risk of hospitalization or death in study subjects with mild to moderate Covid-19 by about 50%, the companies said on Friday.

The drug, called molnupiravir, performed so well in its late-stage trial that Merck and Ridgeback said they stopped recruiting subjects after discussions with the U.S. Food and Drug Administration.
The results put molnupiravir on track to potentially be cleared by the end of the year and to finally offer an option for doctors who have passed the pandemic to seek a drug that those infected could easily take at home to avoid that they are not hospitalized.

Merck plans to ask the FDA to clear the drug for use in the coming weeks, CEO Rob Davis said.

If cleared by regulators, the drug would be the first oral antiviral for Covid-19.

Molnupiravir would become a kind of Tamiflu for Covid-19, a drug that can be delivered to patients when they first develop symptoms, slowing the spread of the virus in the body and potentially preventing people from getting seriously ill.

Covid-19 deaths reported daily in the United States

Notes: For all 50 states and DC, US territories and cruises. Last update

Source: Johns Hopkins Center for Systems Science and Engineering

“The ability to take what is a devastating disease like Covid-19 and potentially make it a manageable situation through what is a very convenient administration cycle, which is an oral pill that you can take at home,” has important implications for the ability to manage the ongoing pandemic, ”said Davis.

Merck and Ridgeback reported the results in a press release after a first look at the results of the study, which is expected to end in November. The results have not been published in a peer-reviewed scientific journal.

The companies said the rate of side effects in study subjects who received molnupiravir and those who received placebo was similar, although they did not indicate in their press release whether the drug was safe in the study. Mr Davis, however, said he was confident in the drug’s safety profile.

The drug has been shown to be effective against circulating variants of Covid-19, including the highly contagious Delta, according to the companies.

The findings position Kenilworth, NJ-based Merck, one of the world’s largest drugmakers, to play a larger role in the pandemic response after several setbacks. After testing failed for its two experimental vaccines, Merck agreed to help make Johnson & Johnson‘s

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Pull. Merck also halted development of an investigational drug it acquired through a $ 425 million purchase.

Merck said it plans to produce 10 million treatments by the end of the year, with more doses coming next year. If allowed, Merck would start shipping doses fairly quickly, Davis said.

The United States has agreed to pay Merck $ 1.2 billion for 1.7 million treatments, if regulators give the green light for the use of molnupiravir.

Merck said it plans to make the drug available worldwide and has licensing agreements with generic manufacturers to deliver the drug to low-income countries, many of which have had difficulty accessing vaccines to slow the spread. spread of the virus.

Vaccines are the main weapon in the fight against the pandemic, but doctors and health officials have long sought drugs that can help prevent those infected from developing serious illness and needing hospitalization.

Almost two years after the start of the pandemic, however, drug options are limited. Remdesivir, from Gilead Sciences Inc.,

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is the only antiviral fully approved by the FDA, but is only used to treat hospital patients.

The FDA has cleared antibody-based drugs manufactured by companies like Regeneron Pharmaceuticals Inc.

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et GlaxoSmithKline GSK -0,31%

PLC and its partner Vir Biotechnology Inc.

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for people with mild to moderate Covid-19 who are not hospitalized. However, the drugs are more complicated to administer than swallowing a pill, requiring an intravenous infusion, which initially slowed their absorption.

One of the most effective drugs against Covid-19, a steroid called dexamethasone, is for very sick patients.

Molnupiravir was originally developed by a not-for-profit biotechnology company owned by Emory University. Ridgeback then licensed and formed a collaboration with Emory in early 2020 and then announced a partnership with Merck.

Molnupiravir works by attacking a part of the virus that is different from the peak protein on the coronavirus commonly targeted by Covid-19 vaccines and other Covid-19 drugs. The part attacked by molnupiravir helps the virus to reproduce.

“Now you will have an oral, easily accessible and easily dispensed drug to keep people from going to the hospital and keep them from dying,” said Wayne Holman, co-founder of Miami-based Ridgeback.

Other companies are also developing Covid-19 antivirals, including Pfizer Inc.,

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as well as Roche Holding AG and Atea Pharmaceuticals Inc.

Merck and Ridgeback stopped a study of molnupiravir in hospital patients in April, after researchers found it wasn’t helping them and is unlikely to reduce hospital stays and deaths.

Companies continued to study whether the antiviral was effective early in the disease and in people at high risk for complications from Covid-19. Antivirals tend to be more effective when taken soon after infection and become less beneficial over time as patients get sicker, doctors and scientists say.

The advanced stage, or phase 3, Merck-Ridgeback study recruited more than 1,400 people at high risk of becoming seriously ill with Covid-19. About half received an 800 milligram dose of molnupiravir twice a day for five days, with the remaining participants receiving a placebo.

High risk was defined as having at least one characteristic associated with serious illness or death, such as old age, obesity or diabetes. Treatment began within five days after participants developed symptoms of Covid-19.

In the interim analysis, 28 of 385 subjects who received the drug were hospitalized or died after 29 days, said Merck and Ridgeback, compared with 53 of 377 subjects in the placebo group, which yielded an efficacy rate of d ‘about 50%.

During the 29 days, no subject who received molnupiravir had died, compared with eight deaths in the placebo group, according to the companies.

The interim review of the drug’s efficacy and safety was carried out by an external group of independent experts known as the Data Safety Oversight Committee, who then shared their findings with Merck and Ridgeback. .

The panel met on Tuesday evening to review the data and then recommended stopping the study due to the positive results, Dr Holman said. The companies then went to the FDA with this recommendation.

Mr Davis said researchers would still do a final analysis, which could mean the percentage of effectiveness is adjusted, but the overall positive result should not change. He said the study subjects who were given a placebo would be offered molnupiravir.

Merck and Ridgeback said in September that they had started a separate trial to see if molnupiravir could prevent infection in people after exposure to the virus.

Write to Jared S. Hopkins à [email protected] and Betsy McKay at [email protected]

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