LONDON (AP) – The UK granted conditional approval on Thursday for the first pill to successfully treat COVID-19 to date. It is also the first country to approve a treatment from drug manufacturer Merck, although it was not immediately clear how soon the pills would be available.
The tablet has been licensed for adults 18 and older who test positive for COVID-19 and have at least one risk factor for developing a serious illness such as obesity or heart disease. Mild to moderate COVID-19 patients should take four tablets of a drug known as molnupiravir twice daily for five days.
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Antiviral pills that reduce symptoms and speed recovery could be revolutionary, reducing the burden on hospitals and helping contain outbreaks in poorer countries with fragile health systems. It will also strengthen a two-pronged approach to the pandemic: drug treatment and prevention, primarily through vaccination.
Molnupiravir is also awaiting regulatory review from the United States, the European Union and other countries. Last month, the US Food and Drug Administration announced that it would convene a group of independent experts to study the safety and effectiveness of the pills in late November.
Initial shipments will be limited. Merck said it could deliver 10 million treatments by the end of the year, but much of that proposal has already been procured by governments around the world.
In October, UK officials announced they had secured 480,000 courses of molnupiravir and expect thousands of vulnerable Britons to access treatment this winter thanks to a nationwide study.
“Today is a historic day for our country as the UK became the first country in the world to approve an antiviral drug that can be taken at home to treat COVID-19,” said UK Health Minister Sajid Javid.
“We are working at a pace across government and with the NHS to develop plans for early introduction of molnupiravir to patients as part of a national study,” he said in a statement referring to the UK’s National Health Service. The doctors said that treatment will be especially important for people who do not respond well to vaccinations.
Merck and partner Ridgeback Biotheotherapy have requested drug approval from regulatory agencies around the world for adults with early cases of COVID-19 who are at risk of serious illness or hospitalization. This is roughly the same group that is targeting treatment with drugs injected with COVID-19 antibodies, which in many countries are the standard of care for patients who do not yet need hospitalization.
In September, Merck announced preliminary results that halved hospital admissions and deaths among patients with early symptoms of COVID-19. The results have not yet been peer reviewed and published in a scientific journal.
The company also did not disclose details of the side effects of molnupiravir, except that it noted that the frequency of these problems was similar between people who took the drug and those who took pacifiers.
The drug targets an enzyme that the coronavirus uses to replicate itself, inserting errors in its genetic code that slow down its ability to spread and invade human cells. This genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.
The British Medicines and Health Products Agency said that the ability of molnupiravir to interact with DNA and cause mutations was studied “extensively” and was not found to be dangerous to humans.
“Studies in rats have shown that (molnupiravir) may have harmful effects on unborn offspring, although this was at doses higher than those that would be given to humans and these effects have not been seen in other animals,” the report said. agencies. email.
In company trials, both men and women were asked to either use contraception or abstain from sex. Pregnant women were excluded from the study. Merck has stated that the drug is safe when used as directed.
Molnupiravir was initially studied as a potential treatment for influenza with financial support from the US government. Last year, researchers at Emory University decided to use the drug as a potential treatment for COVID-19. They then licensed the drug to Ridgeback and a Merck partner.
Last week, Merck authorized other drug makers to make its COVID-19 pills to help millions of people in poorer countries gain access. The Medicines Patent Pool, a UN-backed group, said Merck will not receive royalties under the agreement until the World Health Organization considers COVID-19 a global emergency.
But the deal has been criticized by some activists for excluding many middle-income countries capable of producing millions of procedures, including Brazil and China.
However, experts praised Merck for agreeing to widely disseminate its formula and for its promise to help any companies in need of technological assistance to create their drugs – something no coronavirus vaccine manufacturer has agreed to.
“Unlike the grotesquely unequal distribution of COVID-19 vaccines, the poorest countries do not have to wait at the end of the queue for lightnupiravir,” said Dr. Mohga Kamal-Yanni, senior health adviser to the People’s Vaccine Alliance. Less than 1% of the world’s COVID-19 vaccines have gone to poor countries, and experts hope that easier-to-use drugs will help them curb the pandemic.
Merck previously announced licensing deals with several Indian generic manufacturers to produce cheaper versions of molnupiravir for developing countries.
The US agreed to pay approximately $ 700 for a course of treatment for approximately 1.7 million procedures. Merck says it plans to use a tiered pricing strategy for developing countries. A survey by Harvard University and King’s College London estimated the cost of the drug at about $ 18 for a 40-pill course of treatment.
Although other therapies are approved for the treatment of COVID-19, including steroids and monoclonal antibodies, they are given by injection or infusion and are mainly used in hospitals and other healthcare settings.
This was reported by Matthew Perrone from Washington.