LONDON (AP) — Britain has granted a conditional authorization to Merck’s coronavirus antiviral, the first pill shown to successfully treat COVID-19. The treatment was approved by the UK for the first time, though it is not known how soon the pill will be made available.
Adults 18 years and over who tested positive for COVID-19, and are at least one of the risk factors for severe diseases such as heart disease or obesity were allowed to take this pill. Molnupiravir is a drug that can be used twice daily for up to five days to treat mild or moderate COVID-19.
The discovery of an antiviral pill which reduces symptoms and accelerates recovery might prove to be a game changer. This could decrease the number of hospital admissions as well as help curb epidemics in fragile countries. This would support the dual-pronged pandemic approach: prevention and treatment with medication.
Molnupiravir remains under review by regulators across the U.S. and Europe. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.
The initial supplies of treatment courses will be very limited. Although Merck claims it will produce 10,000,000 treatment courses by the end of this year, governments around the world have already purchased large quantities of that stock.
Officials from the U.K. announced that they had secured 480,000 molnupiravir courses and expect thousands of Britons to be able to access it this winter through a nationwide 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 Britain’s health secretary, Sajid Javid.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said in a statement, referring to the U.K.’s National Health Service. The treatment will be especially important for those who are not responding to vaccines, according to doctors.
Merck and Ridgeback Biotherapeutic, its global partner, have sought approval from regulators to allow the drug to be used for adults suffering from mild-to-moderate levels of COVID-19. This is for treatment of patients at high risk of serious disease or hospitalization. That’s roughly the same group targeted for treatment with infused COVID-19 antibody drugs, the standard of care in many countries for patients who don’t yet require hospitalization.
Merck reported preliminary findings last month showing that its drug has reduced deaths and hospitalizations in half of patients who have COVID-19 early symptoms. Results have yet to be peer reviewed and published in a scientific publication.
The company also did not disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.
Coronavirus is known for using an enzyme to reproduce, and the drug injects mistakes into its genetic code to slow down its ability to take over cells. Independent experts have questioned whether mutations in the drug can cause birth defects and tumors.
Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it was not found to pose a risk to humans.
“Studies in rats showed that (molnupiravir) may cause harmful effects to the unborn offspring, although this was at doses which were higher than those that will be given to humans, and these effects were not observed in other animals,” the agency said in an email.
Both men and women received instructions in company trials to use contraception, or refrain from having sex. Women who were pregnant were not included in the study. Merck claims that the drug works well when taken as prescribed.
Molnupiravir, originally a possible flu treatment with U.S. funding, was first studied. Emory University’s researchers repurposed the drug last year as a COVID-19 therapy. The drug was then licensed to Ridgeback Pharmaceuticals and Merck.
Merck, a drugmaker, agreed last week to let other manufacturers make the COVID-19 medication. This move was made in an effort to help millions in less developed countries. According to the Medicines Patent Pool (a United Nations-backed organization), Merck won’t receive royalties in the deal for so long as COVID-19 is deemed a global emergency by the World Health Organization.
Some activists criticized the agreement for leaving out middle-income countries that could afford millions of treatment options, such as Brazil and China.
Still, experts commended Merck for agreeing to widely share its formula and promising to help any companies who need technological help in making their drug — something no coronavirus vaccine producers have agreed to.
“Unlike the grotesquely 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-Yanni, a senior health adviser to the People’s Vaccine Alliance. Fewer than 1% of the world’s COVID-19 vaccines have gone to poor countries and experts hope easier-to-dispense treatments will help them curb the pandemic.
Merck had previously signed licensing agreements for lower-cost versions molnupiravir in developing countries with Indian generic drug manufacturers.
For approximately 1.7million treatments, the U.S. spent $700 per treatment. Merck claims it will use tiered pricing strategies for developing nations. A review by Harvard University and King’s College London estimated the drug costs about $18 to make.
Other treatments for COVID-19 have also been approved, such as steroids or monoclonal antibody treatment. However, these are usually administered via injections or infusions and are only available to hospitalized patients.
Matthew Perrone reports from Washington.
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