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The UK authorized Merck’s COVID pill. It’s the first shown to treat COVID-19

Video above: Merck seeks FDA emergency use authorization for antiviral COVID-19 treatment molnupiravirBritain has granted conditional permission to Merck’s coronavirus antiviral drug. This is the first tablet to successfully treat COVID-19. It wasn’t immediately clear how quickly the pills would be available, but it was the first country to accept treatment. The pill was tested positive for COVID-19 and was approved for adults over the age of 18 who have at least one risk factor for developing severe illness. Known as molnupiravir, the drug is intended for people in households with mild to moderate COVID-19 to take twice daily for 5 days. Antiviral drugs that reduce symptoms and speed recovery may prove groundbreaking, reduce hospital cases, and help control outbreaks in poor countries with fragile health care systems. .. It also enhances two approaches to the pandemic: dosing treatment and predominantly vaccination prophylaxis. Molnupiravir is also awaiting review by US, European and other regulatory agencies. The US Food and Drug Administration announced last month that it would convene a panel of independent experts to scrutinize the safety and efficacy of pills in late November. Initial supply is limited. Merck says it can create 10 million treatment courses by the end of the year, but much of its supply has already been purchased by governments around the world. In October, British officials secured 480,000 courses in Molnupiravir, with thousands of vulnerable British access to treatment this winter in a national survey. UK Health Minister Sajid Javid said, “Today is a historic day for our country as it is the first country in the world to approve an antiviral drug that can be taken at home for COVID-19. That’s it. ” At the pace of the entire government and NHS, we plan to deploy molnupiravir to patients through a national survey as soon as possible, “he said in a statement referring to the United Kingdom’s National Health Service. Doctors said treatment was especially important for people who did not respond well to vaccination. Merck and its partner, Ridgeback Biotherapeutic, are seeking approval from regulators around the world to treat adults with mild to moderate COVID-19 who are at risk of severe illness or hospitalization. This is similar to the group treated with infused COVID-19 antibody drugs, which is the standard treatment in many countries for patients who do not yet require hospitalization. With early COVID-19 symptoms. The results have not yet been scrutinized by outside scientists. Also, details of the side effects of molnupiravir are not disclosed, except that the incidence of these problems is similar between those who took the drug and those who took dummy tablets. The drug targets the enzyme that the coronavirus uses to replicate itself, inserting errors into the genetic code and delaying the ability of human cells to spread and take over. Its genetic activity has led some independent experts to question whether the drug can cause mutations that lead to birth defects and tumors. In company trials, both men and women were instructed to use contraception or refrain from gender. Pregnant women were excluded from the study. Merck states that the drug is safe when used as directed. Molnupiravir was initially funded by the US government and studied as a potential treatment for influenza. Last year, researchers at Emory University decided to reuse the drug as a potential treatment for COVID-19. They then licensed the drug to Ridgeback and its partner Merck. Last week, Merck agreed to allow other pharmaceutical companies to make COVID-19 pills in a move aimed at making it accessible to millions of people in poor countries. The United Nations-backed group Medicines Patent Pool said Merck would not receive consensual royalties as long as the World Health Organization considers COVID-19 to be a global emergency. However, the deal has been criticized by some activists for excluding many middle-income countries that can provide millions of treatments, such as Brazil and China. Still, experts agree that Merck will share its prescription widely and support companies that need technical assistance in the manufacture of medicines, which the producers of coronavirus vaccines do not agree with. I praised the promise. “Unlike the grotesque and unequal distribution of the COVID-19 vaccine, the poorest countries do not have to wait behind the Molnupiravir line,” said Dr. Moga Kamal Yanni, senior health adviser to the People’s Vaccine Alliance. rice field. Less than 1% of the world’s COVID-19 vaccine goes to poor countries, and experts hope that simpler treatments will help control the pandemic. Earlier, Merck announced licensing agreements with several Indian generic pharmaceutical companies, and the United States reportedly paid about $ 700 per Molnupiravir course for about 1.7 million treatments. Merck states that it plans to use a gradual pricing strategy for developing countries. A review by Harvard University and King’s College London estimates that the drug will cost about $ 18. Other treatments for treating COVID-19, such as steroids and monoclonal antibodies, have been approved, but they are given by injection or infusion and are primarily intended for inpatients. ___ Matthew Perone reported from Washington.

Video above: Merck seeks FDA emergency use authorization for antiviral COVID-19 treatment molnupiravir

The UK has granted conditional approval to Merck’s coronavirus antiviral drug. This is the first pill to successfully treat COVID-19. It wasn’t immediately clear how quickly the pills would be available, but it was the first country to accept treatment.

The pill was tested positive for COVID-19 and was approved for adults over the age of 18 who have at least one risk factor for developing severe illness. Known as molnupiravir, the drug is intended for people in households with mild to moderate COVID-19 to take twice daily for 5 days.

Antiviral drugs that reduce symptoms and speed recovery may prove groundbreaking, reduce hospital cases, and help control outbreaks in poor countries with fragile health care systems. .. It will also reinforce a two-sided approach to pandemics: dosing treatment and predominantly vaccination prophylaxis.

Molnupiravir is also awaiting review by US, European and other regulatory agencies. The US Food and Drug Administration announced last month that it would convene a panel of independent experts to scrutinize the safety and efficacy of pills in late November.

Initial supply is limited. Merck says it can create 10 million treatment courses by the end of the year, but much of its supply has already been purchased by governments around the world.

In October, British officials announced that they had secured 480,000 courses in Molnupiravir and, through a national survey, predicted that thousands of vulnerable British people could be treated this winter.

UK Health Minister Sajid Javid said, “Today is a historic day for our country as it is the first country in the world to approve an antiviral drug that can be taken home for COVID-19. “.

“We are planning to deploy molnupiravir to patients as soon as possible through a national survey in collaboration with the entire government and NHS,” he said in a statement, referring to the United Kingdom’s National Health Service. Doctors said treatment was especially important for people who did not respond well to vaccination.

Merck and its partner, Ridgeback Biotherapeutic, are seeking approval from regulators around the world to treat adults with mild to moderate COVID-19 who are at risk of severe illness or hospitalization. This is about the same group for treatment with infused COVID-19 antibody drugs, which is the standard treatment in many countries for patients who do not yet require hospitalization.

Last month, Merck released preliminary results showing that it halved hospitalization and mortality in patients with early symptoms of COVID-19. The results have not yet been scrutinized by outside scientists.

The company also did not provide details on the side effects of molnupiravir, but said the incidence of these problems was similar between those who took the drug and those who took dummy tablets.

The drug targets the enzyme that the coronavirus uses to replicate itself, inserting errors into the genetic code and delaying the ability of human cells to spread and take over. Its genetic activity has led some independent experts to question whether the drug can cause mutations that lead to birth defects and tumors.

In company trials, both men and women were instructed to use contraception or refrain from having sex. Pregnant women were excluded from the study. Merck states that the drug is safe when used as directed.

Molnupiravir was initially funded by the US government and studied as a potential treatment for influenza. Last year, researchers at Emory University decided to reuse the drug as a potential treatment for COVID-19. They then licensed the drug to Ridgeback and its partner Merck.

Last week, Merck agreed to allow other pharmaceutical companies to make COVID-19 pills in a move aimed at making it accessible to millions of people in poor countries. The United Nations-backed group Medicines Patent Pool said Merck would not receive consensual royalties as long as the World Health Organization considers COVID-19 to be a global emergency.

However, the deal has been criticized by some activists for excluding many middle-income countries that can provide millions of treatments, such as Brazil and China.

Still, experts agree that Merck will share its prescription widely and support companies that need technical assistance in the manufacture of medicines, which the producers of coronavirus vaccines do not agree with. I praised the promise.

“Unlike the grotesque and unequal distribution of the COVID-19 vaccine, the poorest countries do not have to wait behind the Molnupiravir line,” said Dr. Moga Kamal Yanni, senior health adviser to the People’s Vaccine Alliance. rice field. With less than 1% of the world’s COVID-19 vaccine infecting poor countries, experts hope that easier-to-administer treatments will help control pandemics.

Earlier, Merck announced license agreements with several Indian generic drug manufacturers to produce low-cost versions of drugs for developing countries.

The United States reportedly paid about $ 700 per Molnupiravir course for about 1.7 million treatments. Merck states that it plans to use a gradual pricing strategy for developing countries. A review by Harvard University and King’s College London estimates that the drug will cost about $ 18.

Other treatments for treating COVID-19, such as steroids and monoclonal antibodies, have been approved, but they are given by injection or infusion and are primarily intended for inpatients.

___

Matthew Perone reported from Washington.

The UK authorized Merck’s COVID pill. It’s the first shown to treat COVID-19 Source link The UK authorized Merck’s COVID pill. It’s the first shown to treat COVID-19

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