LONDON (AP) – Britain has granted conditional authorization to Merck’s coronavirus antiviral, the first pill shown to successfully treat COVID-19. It is the first country to fix the treatment, although it was not immediately clear how soon the pill would be available.
The pill was licensed for adults 18 years of age and older who have tested positive for COVID-19 and have at least one risk factor for developing a serious illness, such as obesity or heart disease. The drug, known as molanupiravir, is intended to be taken at home by people with mild to moderate COVID-19 twice a day for five days.
An antiviral pill that eases symptoms and speeds recovery could prove unprecedented, easing caseloads on hospitals and helping contain outbreaks in poor countries with weak health systems. It will also strengthen a two-pronged approach to the pandemic: treatment, through medicine, and prevention, primarily through vaccination.
Molnupiravir is also pending review by regulators in the US, EU and elsewhere. The US Food and Drug Administration announced last month that it would convene a panel of independent experts in late November to examine the pill’s safety and effectiveness.
Initial supply will be limited. Merck has said it could produce 10 million treatment courses by the end of the year, but much of that supply has already been procured by governments around the world.
In October, UK officials announced they had secured 480,000 courses of mollupiravir and hoped that thousands of vulnerable Britons would get treatment this winter through a national study.
Britain’s Health Secretary, Sajid Javid, said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be used at home for COVID-19.” can be moved.”
“We are working closely with the government and the NHS to develop plans to deploy mollupiravir to patients as soon as possible through a national study,” he said in a statement, referring to the UK’s National Health Service. Doctors said the treatment would be especially important for people who do not respond well to vaccination.
Merck and its partner Ridgeback Biotherapeutics have requested approval for the drug with regulators around the world to treat adults with mild to moderate COVID-19 who are at risk of severe illness or hospitalization. This is broadly the same group targeted to treat infected COVID-19 with antibody drugs, the standard of care in many countries for patients who have not yet required hospitalization.
Merck announced preliminary results last month that showed the drug cut hospitalizations and more than half of deaths in patients with early COVID-19 symptoms. The results have not yet been reviewed or published in a scientific journal.
The company did not disclose details about the side effects of molnupiravir, except that the rates of those problems were similar between people getting the drug and those receiving counterfeit pills.
The drug targets an enzyme that the coronavirus uses to reproduce itself, inserting errors in its genetic code that slow down the ability of human cells to spread and take over. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations that could lead to birth defects or tumors.
Britain’s Medicines and Healthcare products Regulatory Agency said mollupiravir’s ability to interact with DNA and cause mutations was “extensively” studied and was not found to pose a risk to humans.
The agency said, “Studies in rats have shown that[molenupiravir]may cause harmful effects to unborn babies, although this dose was higher than those that would be given to humans, and these effects did not occur in other animals.” were seen.” an email.
In company trials, both men and women were instructed to either use contraception or 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 flu therapy with funding from the US government. Last year, researchers at Emory University decided to reuse the drug as a potential COVID-19 treatment. He then licensed the drug to Ridgeback and his partner, Merck.
Last week, Merck agreed to allow other drugmakers to make its own COVID-19 pill, aimed at helping millions of people in poor countries gain access. The United Nations-backed group, the Medicines Patent Pool, said Merck would not receive royalties under the agreement unless 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.
Still, experts applauded Merck for agreeing to share its formula widely and pledged to help any company that needs technical help making its drug — something that could be used as a coronavirus vaccine. The producers do not agree.
“Unlike the unequal distribution of COVID-19 vaccines, the poorest countries will not have to wait at the back of the queue for Molnupiravir,” said Dr. Mohga Kamal-Yani, a 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 are hopeful that easy-to-access treatment will help them curb the pandemic.
Earlier, Merck had announced licensing deals with several Indian manufacturers of generic drugs to manufacture low-cost versions of molnupiravir for developing countries.
The US reportedly paid about $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 King’s College London estimated the cost of the drug to be around $18.
While other treatments have been approved to treat COVID-19, including steroids and monoclonal antibodies, which are administered by injection or infusion and are mostly for hospitalized patients.
Matthew Perrone reported from Washington.
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