LONDON, NOV 4 (BUS) : Britain has granted a conditional authorization of Merck’s anti-coronavirus, the first pill proven to be successful in treating COVID-19. It is the first country to approve the treatment, although it was not immediately clear how quickly the pill would be available.
The pill is licensed for adults age 18 and older who have tested positive for COVID-19 and have at least one risk factor for serious illness, such as obesity or heart disease. The drug, known as molnopiravir, is intended to be taken twice daily for five days by people at home with mild to moderate COVID-19, the AP reports.
Antiviral pills that reduce symptoms and speed recovery could prove groundbreaking, reducing the caseload on hospitals and helping reduce outbreaks in poor countries with fragile health systems. It will also advance a two-pronged approach to the pandemic: treatment with medication and prevention, primarily through vaccinations.
Molnupiravir is also awaiting review in regulatory agencies in the United States, the European Union, and elsewhere. The US Food and Drug Administration announced last month that it would form a panel of independent experts to scrutinize the safety and effectiveness of birth control pills in late November.
Initial supplies will be limited. Merck said it could produce 10 million courses of treatment through the end of the year, but much of that supply has already been purchased by governments around the world.
In October, British officials announced they had taken 480,000 cycles of molnopiravir and expected thousands of at-risk Britons to get treatment this winter through a national study.
Britain’s Health Minister Sajid Javid said: “Today is a historic day for our country, as the UK is now the first country in the world to adopt a take-home antiviral for COVID-19.”
“We are working steadily across government and with the NHS to develop plans to roll out molonoperavir to patients through a national study as soon as possible,” he said in a statement, referring to the UK’s National Health Service. Doctors said treatment would be especially important for people who don’t respond well to vaccination.
Merck and partner Ridgeback Biotherapeutic have requested authorization for the drug with regulators worldwide to treat adults with mild to moderate COVID-19 who are at risk of severe illness or hospitalization. This is roughly the same target group for treatment with COVID-19 antibody drugs, which is the standard of care in many countries for patients who do not yet need to be hospitalized.
Merck announced preliminary results last month showing hospitalizations and deaths were halved among patients with early COVID-19 symptoms. The results have not yet been reviewed or published in a scientific journal.
The company also didn’t reveal details about molopiravir side effects, except to say rates of those problems were similar between people who took the drug and those who took a dummy pill.
The drug targets an enzyme the coronavirus uses to reproduce itself, introducing errors in its genetic code that slow its ability to spread and take over human cells. This gene activity has led some independent experts to question whether the drug could cause mutations that lead to birth defects or tumors.
Britain’s Medicines and Healthcare products Regulatory Agency said the ability of molnopiravir to interact with DNA and cause mutations had been “extensively” studied and not found to pose a risk to humans.
In the report, the agency said: “Studies in mice have shown that (molnopiravir) may cause adverse effects in unborn offspring, although this was at doses higher than those that would be administered to humans, and these effects have not been observed in other animals. “. e-mail.
In the companies’ trials, both men and women were instructed to use contraception or to abstain from sex. Pregnant women were excluded from the study. Merck states that the drug is safe when used as directed.
Molnupiravir was initially studied as a potential treatment for influenza with US government funding. Last year, researchers at Emory University decided to repurpose the drug as a potential treatment for COVID-19. They then licensed the property to Ridgeback and its partner Merck.
Last week, Merck agreed to allow other drug companies to make COVID-19 pills, in a move aimed at helping millions of people in poor countries access them. The Medicines Patents Group, a United Nations-backed group, said Merck will not receive royalties under the agreement as long as the World Health Organization considers COVID-19 a global emergency.
But the deal has been criticized by some activists for excluding several middle-income countries capable of making millions of treatments, including Brazil and China.
However, experts praised Merck for agreeing to share its formula widely and promised to help any company that needs technology help making their drugs — something that coronavirus vaccine producers have not agreed to.
“Unlike the deeply unequal distribution of COVID-19 vaccines, the poorest countries will not have to wait at the back of the molnopiravir waiting list,” said Dr. Mohga Kamal Yani, Senior Health Adviser at the People’s Vaccine Alliance. Less than 1% of the world’s COVID-19 vaccines have gone to poor countries and experts hope easier treatments will help them curb the epidemic.
Merck previously announced licensing deals with several Indian generic drug makers to manufacture low-cost versions of molnopiravir for developing countries.
The United States reportedly paid nearly $700 per course of the drug for about 1.7 million treatments. Merck says it plans to use a tiered pricing strategy for developing countries. A review by Harvard University and Kings College London estimated the cost of the drug to be around $18.
While other therapies have been permitted to treat COVID-19, including steroids and monoclonal antibodies, these are administered by injection or infusion and are mostly for inpatients.