LONDON , – Britain granted conditional approval on Thursday for the first drug to treat COVID-19. The first country to approve the treatment by drugmaker Merck is also in this group, though it was not immediately clear when the pill would become available.
The drug was approved for adults aged 18 or older who tested positive for COVID-19. They also need to have at least one risk factor of developing severe diseases such as heart disease or obesity. For five days, patients with moderate-to-severe COVID-19 should take four pills of the drug known as molnupiravir twice daily.
A pill that reduces symptoms and speeds up recovery could be a game changer. It would help to lessen hospital caseloads and prevent outbreaks in countries with weaker health systems. It would also strengthen the two-pronged approach of the pandemic: prevention and treatment with medication.
Molnupiravir remains under review by regulators in the U.S. and the European Union. Last month, the U.S. Food and Drug Administration announced that it would convene an independent panel to examine the effectiveness and safety of the pill in late November.
Initial supplies will be very limited. Although Merck claims it can produce 10,000,000 treatment courses by the end of this year, governments around the world have already purchased large quantities of this supply.
Officials from the U.K. announced that they had secured 480,000 molnupiravir courses and that thousands of Britons would be able to access it through a national study.
Sajid Javid, British health secretary, said that today was a historic day in Britain. The U.K. has approved an antiviral which can be taken at home for COVID-19.
He said that he was working with the NHS and the government to develop plans to distribute molnupiravir among patients in the UK’s National Health Service. Doctors stated that the treatment would be especially important for those who aren’t responding to vaccination.
Merck and Ridgeback Biotherapeutic, Ridgeback’s partner, have asked for approval from regulators worldwide for the drug for adults with COVID-19 early cases who are at high risk of serious illness or hospitalization. This is the same group that will be treated with infused COVID-19 antibodies drugs. In many countries, this is the standard of care for patients who don’t require hospitalization.
Merck released preliminary results in September that showed its drug reduced hospitalizations and deaths for patients suffering from COVID-19 symptoms. These preliminary results have not yet been peer reviewed and published in a scientific journal.
The company did not disclose any details about molnupiravir side effects. However, it did say that the rates of these problems were comparable between those who took the drug and those who took dummy pills.
The drug targets the enzyme that coronavirus uses for reproduction. It inserts errors into its genetic code to slow down its ability to spread and overtake human cells. Independent experts have questioned whether the drug could cause birth defects or tumors due to its genetic activity.
The British Medicines and Healthcare products Regulatory Agency stated that molnupiravir’s potential to interact with DNA and cause genetic mutations was well-studied and not a danger to human health.
The agency stated in an email that “Studies in rats have shown that (molnupiravir), may cause harm to the unborn offspring. However, this was at higher doses than the ones that will be given humans and these effects were not observed elsewhere.”
Both men and women were asked to use contraception in company trials. The study excluded pregnant women. Merck stated that the drug is safe if used according to instructions.
Molnupiravir, originally a potential treatment for flu, was funded by the U.S. government. Emory University researchers decided last year to repurpose the drug for a possible COVID-19 treatment. The drug was then licensed to Ridgeback Pharmaceuticals and Merck.
Merck last week agreed to let other drugmakers make the COVID-19 medication. This move was made in an effort to help millions of people in less developed countries access the medicine. The Medicines Patent Pool, a U.N.-backed organization, stated that Merck would not be paid royalties under the agreement until the World Health Organization declares COVID-19 a global emergency.
Some activists criticized the deal for leaving out middle-income countries that could afford millions of treatments, such as Brazil and China.
Experts praised Merck for sharing its formula widely and promising to assist any company that needs technological assistance in making their drug. This is something that no coronavirus vaccine manufacturers have done.
“Unlike the grotesquely uneven distribution of COVID-19 vaccinations, the poorest nations will not have to wait at least a few minutes for molnupiravir,” Dr. Mohga Kazal-Yanni, a Senior Health Advisor to the People’s Vaccine Alliance, said. Experts believe that less than 1% of COVID-19 vaccines worldwide have been distributed to poor countries. They hope that easier-to-dispense treatments can help curb the pandemic.
Merck has previously signed licensing agreements with several Indian manufacturers of generic drugs in order to produce lower-cost versions for developing countries of molnupiravir.
The U.S. agreed to pay $700 for approximately 1.7 million courses of the drug. Merck states that it will use a tiered pricing strategy to treat developing countries. According to King’s College London and Harvard University, each 40-pill treatment costs approximately $18.
Other treatments for COVID-19 have been approved, including monoclonal antibodies and steroids. However, these are administered via injections or infusions and are most commonly used in hospitals and other healthcare facilities.
