Merck’s oral COVID-19 pill seeks FDA’s safety and efficacy approval for emergency usage
Merck applied for FDA in October to give assent to its experimental drug named molnupiravir, which is being considered for mild-to-moderate Covid-19 symptoms, for administration to adults. The pill is recommended for those who are at a risk for hospitalization as well.
If the pill clears the scrutiny, it shall be the first of its kind, anti-viral pill to treat the virus, as all other methods require an injection or IV. Many experts working at the Food and Drug Administration are expected to gather on Tuesday to make a call on its recommendation, and usage for Covid-19.
Dr. David Boulware, an infectious disease physician at the University of Minnesota Medical School, Physicians are still going to want to “recommend monoclonal antibodies. They’re better,”. “Still, this is kind of an option for people that don’t have access to those treatments or other factors come into play.”
Sharing his expectations, he said there is a possibility that the drug may be permitted for usage for the most high-risk adults. Although the efficacy was tested to be way lower than anticipated, it may be able to curb the disease at its roots.
“The benefit of being able to prescribe something in the middle of the night or on weekends, and have a patient just go to their local pharmacy to pick up the pills cannot be overstated,” Boulware said.
The company had released results on Friday which showed that the pill helped cut down the risk of hospitalization by almost one-third. Another bidder for a pill made one in October which was more effective and reduced hospitalizations by half, whereas the treatments getting chosen are showing the efficacy of bringing down the risk of severe outcomes by at least 70%.
The drug functions by introducing errors or mutations into the virus’s genetic material, making it hard for the virus to multiply itself. Unlike other anti-viral pills, developers of the vaccine suggest its intake during early detection of the diseases to prove effective, in the test by the company it was introduced to the subject within 5 days of symptoms’ onset.