The European Union medicines regulator is starting to review Merck’s antiviral drug COVID-19, which is taken as an oral pill.
Experts have said the drug is a potential ‘game changer’ for the pandemic as the first Covid treatment that would not require needles or intravenous drains.
A clinical trial has found that the pill halves the risk of hospitalization and death from Covid for patients at high risk due to their age or medical condition.
The review by the European agency follows several major orders for the pill from Merck, including the purchase by France of 50,000 doses.
Merck applied for emergency use authorization from the United States Food and Drug Administration (FDA) earlier in October. If approved, the United States will receive over a million doses.
Merck’s antiviral pill could be a game-changer as the first Covid drug to not require needles and intravenous infusions. Pictured: Merck’s pills, in a photo released by the company
Vaccines remain the most effective tools to protect people against Covid infection, serious illness and death.
But for people particularly vulnerable to severe symptoms and for areas of the world that do not yet have easy access to vaccines, drugs are an important part of Covid mitigation.
To that end, an antiviral drug made by US pharmaceutical company Merck is gaining momentum as a potential “game changer” for the future of the pandemic.
On Monday, the company announced that it had asked the European Medicines Agency (EMA) to review its drug for approval.
The EU medicines regulatory authority will conduct a ‘continuous review’, during which the agency will review the data as the information becomes available.
This type of review speeds up the approval process, as the agency does not need to wait for a formal request with all the necessary data.
Merck developed this pill – officially named molnupiravir – with Ridgeback Biotherapeutics, a biotechnology company headquartered in Miami, Florida.
The drug works by interfering with the genetic material of the coronavirus, blocking the virus’s ability to replicate after a patient has been infected.
Patients at high risk for severe symptoms of Covid can take it after learning that they have been infected with the virus.
In the Merck clinical trial, patients took the pill as four capsules, twice a day, for five days.
This diet began five days after patients first experienced symptoms of Covid.
Merck’s trial found the pill to be very effective – it halved the risk of patients being hospitalized or dying from Covid.
In fact, the initial trial results were so promising that an independent review committee recommended that Merck end the trial sooner.
Researchers saw no major side effects in the clinical trial, which focused on testing the drug in high-risk patients, including adults over the age of 60 and people with diabetes, heart disease and obesity.
The Merck pill was designed for patients at high risk of severe Covid due to their age or medical condition. Pictured: Merck’s logo on the company’s New Jersey campus, July 2018
If the pill is approved by drug regulators, it would be the first Covid drug to be given orally – rather than with a needle or intravenous drip.
The EU is preparing to buy a large number of doses if the EMA approves the drug.
Merck also filed for emergency use authorization with the US FDA in early October. An advisory committee is due to meet and discuss the drug in late November.
If the FDA clears the drug, the United States would have to purchase 1.7 million doses at $ 700 for the number of pills a patient would need during a five-day course.
In addition, France recently ordered 50,000 doses, the country announced on Tuesday.
Other countries, including the UK, Australia, Malaysia and Singapore, already have contracts in place.
Some global health experts fear that Merck’s pill will follow the same patterns as Covid vaccines, in which high-income countries receive more doses while low-income countries are unable to purchase the drug.
But Merck is committed to providing fair and timely access to the drug around the world and has sought to license it to other manufacturers, Al Jazeera reports.