The second tablet against COVID-19 was approved by US health regulators on Thursday, giving another easy-to-use treatment to combat the rising flood of omicron illnesses.
The FDA’s approval comes just one day after the agency gave Pfizer permission to market a competitive medicine. Because of its higher benefits and fewer side effects, that medication is likely to become the first-line treatment for the infection.
As a result, Merck’s tablet is expected to play a smaller role in the pandemic than was previously predicted. Its effectiveness to prevent severe COVID-19 is significantly lower than expected, and the medicine label will include a warning about serious safety concerns, including the risk of birth defects.
Merck’s medicine has been approved by the Food and Drug Administration for persons with early COVID-19 symptoms who are at high risk of hospitalisation, such as the elderly and those with comorbidities including obesity and heart disease. The pill was originally approved in the United Kingdom in early November. The Merck medicine, known as molnupiravir, will come with a warning that it should not be used during pregnancy.
The restrictions were expected when an FDA advisory group barely approved the medicine last month, warning that it would need to be used only by patients who would benefit the most.
The Pfizer tablet works differently and has fewer side effects. In addition, Pfizer’s medicine was almost three times more successful in testing, lowering hospitalisation and death among high-risk patients by nearly 90%, compared to 30% for Merck’s. Some analysts doubt that the Merck drug will play a significant role in the United States.
“I don’t think the Merck drug will be used to the extent that there is a sufficient supply of Pfizer’s tablet,” said Dr. Gregory Poland of the Mayo Clinic, referring to the Merck drug. “There would be no justification given the lower efficacy and increased likelihood of unwanted effects.”
Even as health officials prepare for record-breaking cases, hospitalizations, and deaths caused by the omicron variety, the FDA decision provides another potential option against the virus that has killed more than 800,000 Americans. Antiviral medications, such as Merck’s, should be successful against omicron since they don’t target the spike protein, which contains the majority of the variant’s dangerous mutations.
The FDA made its decision based on data revealing that roughly 7% of patients receiving the medicine ended up in the hospital, with one patient dying after 30 days. In comparison, 10% of patients admitted to the hospital were given the control, which resulted in nine fatalities. Officials from the federal government have agreed to buy enough of the medicine to treat 3.1 million individuals.
Each course of Merck’s medicine, which needs patients to take four pills twice a day for five days, will cost roughly USD 700 in the United States. According to a study conducted by Harvard University and King’s College London, each 40-pill treatment cycle costs around USD 18.