LONDON (AP) – Britain on Thursday granted conditional clearance for the first pill that has successfully treated COVID-19 so far. It is also the first country to accept treatment from drug maker Merck, although it was not immediately clear how quickly the pill would be available.
The pill has been approved for adults 18 and older who have tested positive for COVID-19 and who have at least one risk factor for developing serious illness, such as obesity or heart disease. Patients with mild to moderate COVID-19 would take four tablets of the drug, known as molnupiravir, twice a day for five days.
An antiviral pill that reduces symptoms and speeds recovery could prove revolutionary, alleviate hospital cases and help curb epidemics in poorer countries with fragile health systems. It would also strengthen the two-pronged approach to the pandemic: treatment, through drugs, and prevention, mainly through vaccination.
Molnupiravir is also pending review with regulatory agencies in the United States, the European Union and elsewhere. The United States Food and Drug Administration announced last month that it would convene a panel of independent experts to review the safety and effectiveness of the pill in late November.
Initial supplies will be limited. Merck said it could produce 10 million treatments by the end of the year, but much of that supply has already been purchased by governments around the world.
In October, British authorities announced that they had obtained 480,000 courses of molnupiravir and expected thousands of vulnerable Britons to have access to treatment this winter via a national study.
“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 taken at home for COVID-19,” said UK Health Secretary Sajid Javid.
“We are working at a steady pace within government and with the NHS to outline plans to roll out molnupiravir to patients via a nationwide study as soon as possible,” he said in a statement, referring to National Health UK service. Doctors said the treatment would be especially important for people who don’t respond well to the vaccination.
Merck and its partner Ridgeback Biotherapeutic have sought approval of the drug 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 target group for treatment with infused anti-COVID-19 antibodies, the standard of care in many countries for patients who do not yet require hospitalization.
Merck announced preliminary results in September showing that its drugs have halved hospitalizations and deaths in patients with early symptoms of COVID-19. The results have not yet been peer reviewed or published in a scientific journal.
The company also did not disclose details of the side effects of molnupiravir, except to say that the rates of these problems were similar between people who received the drug and those who received dummy pills.
The drug targets an enzyme that the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow down its ability to spread and take hold of 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 UK Medicines and Health Products Regulatory Agency said molnupiravir’s ability to interact with DNA and induce mutations has been “extensively” studied and has not been shown to present. a risk for humans.
“Studies in rats have shown that (molnupiravir) may have harmful effects on unborn offspring, although at higher doses than will be given to humans, and these effects have not been observed. in other animals, ”the agency said in an email.
In company trials, both men and women were instructed to use contraception or to abstain from sex. Pregnant women were excluded from the study. Merck said the drug is safe when used according to directions.
Molnupiravir was initially studied as a potential treatment for influenza with funding from the US government. Last year, researchers at Emory University decided to reuse the drug as a potential treatment for COVID-19. They then cleared the drug to Ridgeback and his partner Merck.
Last week, Merck agreed to allow other drugmakers to manufacture its COVID-19 pill, in a bid to help millions of people in poorer countries gain access to it. The Medicines Patent Pool, a UN-backed group, has said Merck will not receive royalties under the agreement as long as the World Health Organization considers COVID-19 to be a global emergency.
But the deal has been criticized by some activists for excluding many middle-income countries capable of manufacturing millions of treatments, including Brazil and China.
Still, experts praised Merck for agreeing to share its formula widely and for pledging to help all companies that need technological help to manufacture their drug – something no vaccine producer against. the coronavirus did not accept.
“Unlike the grotesquely uneven distribution of COVID-19 vaccines, poorer countries will not have to wait until the queue for molnupiravir ends,” said Dr Mohga Kamal-Yanni, senior advisor in from the People’s Vaccine Alliance. Less than 1% of COVID-19 vaccines globally have gone to poor countries, and experts hope easier-to-deliver treatments will help them curb the pandemic.
Merck previously announced licensing agreements with several Indian generic drug makers to make cheaper versions of molnupiravir for developing countries.
The United States has agreed to pay around $ 700 per drug cycle for around 1.7 million treatments. Merck says it plans to use a tiered pricing strategy for developing countries. A study by Harvard University and King’s College London estimated that the drug costs around $ 18 for each treatment of 40 tablets.
While other treatments have been approved to treat COVID-19, including steroids and monoclonal antibodies, these are given by injection or infusion and are primarily used in hospitals and other healthcare facilities.
Matthew Perrone reported from Washington.
Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic
This story has been corrected to show that Merck announced preliminary results in September, not last month.