Experts have said this drug is a potential ‘game-changer’ for the pandemic as the first Covid treatment that would not require needles or intravenous infusions.
A clinical trial found that the pill halves the risks of Covid hospitalization and death for patients who are at high risk due to their age or medical conditions.
The European agency’s review follows several large orders of Merck’s pill, including France‘s purchase of 50,000 doses.
Merck applied for emergency use authorization at the U.S. Food and Drug Administration (FDA) earlier in October. If it’s approved, the U.S. will receive over one million doses.
Merck’s antiviral pill may be a ‘game-changer’ as the first Covid drug to not require needles or intravenous infusions. Pictured: Merck’s pills, in a photo released by the company
Vaccines continue to be the most effective tools to protect people against Covid infection, severe disease, and death.
But for people who are particularly vulnerable to severe symptoms and for regions of the world that don’t yet have ready access to vaccines, drugs are an important part of mitigating Covid.
To that end, an antiviral drug made by the U.S. pharmaceutical company Merck is gaining momentum as a potential ‘game-changer’ for the future of the pandemic.
On Monday, the company announced that it asked the European Medicines Agency (EMA) to consider its drug for approval.
The EU’s drug regulator will conduct a ‘rolling review,’ in which the agency reviews data as soon as information becomes available.
This type of review expedites the approval process, as the agency does not need to wait for a formal application with all necessary data.
Merck developed this pill – formally named molnupiravir – with Ridgeback Biotherapeutics, a biotech company headquartered in Miami, Florida.
The drug works by interfering with coronavirus genetic material, blocking the virus’s ability to replicate after a patient has been infected.
Patients who are at high risk for severe Covid symptoms can take it after learning that they have been infected by the virus.
In Merck’s clinical trial, patients took the pill in the form of four capsules, twice a day, for five days.
This regimen started five days after patients experienced their initial Covid symptoms.
Merck’s trial found that the pill was highly effective – it halved patients’ risk of being hospitalized or dying from Covid.
In fact, early results from the trial were so promising that an independent evaluation committee recommended that Merck end the trial early.
Researchers did not observe any major side effects in the clinical trial, which focused on testing the drug in high-risk patients – including adults over age 60 and those with diabetes, heart disease, and obesity.
Merck’s pill was designed for patients who are at high risk for severe Covid due to their age or medical conditions. Pictured: Merck’s logo at the company’s campus in New Jersey, 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 infusion.
The EU is set to purchase a large number of doses if the EMA approves the drug.
Merck also applied for emergency use authorization at the U.S. FDA earlier in October. An advisory committee is set to meet and discuss the drug in late November.
If the FDA authorizes the drug, the U.S. is set to purchase 1.7 million doses at $700 for the number of pills one patient would require in a five-day course.
In addition, France has recently ordered 50,000 doses, the country announced Tuesday.
Other countries including the U.K., Australia, Malaysia, and Singapore already have contracts in place as well.
Some global health experts are concerned that Merck’s pill could follow the same patterns as Covid vaccines, in which high-income nations receive more doses while low-income countries are not able to purchase the drug.
But Merck has committed to providing equitable and timely access to the drug around the world and has sought to license it to other manufacturers, Al Jazeera reports.