Today’s clearance adds new treatment for COVID-19, in pill form that can be taken orally, explained a person in charge of FDA, Patrizia Cavazzoni.
Five days after the onset of symptoms
Medically developed by Merck, a laboratory known as MSD outside of the United States and Canada, can be taken within five days of symptom onset, and reduces the risk of hospitalization and death by 30 % among the fragile population.
Wednesday, theFDA approved Pfizer’s treatment, marketed as Paxlovid, which reduces the same risk by 90%, according to clinical trials.
Although vaccination remains the main tool in the fight against the pandemic, experts welcome the arrival of new oral treatments which should, in time, be easily accessible in pharmacies, on presentation of a prescription.
Currently available anti-COVID treatments like monoclonal antibodies or Gilead’s remdesivir are administered intravenously.
Drugs from Pfizer and Merck, which do not target the virus’s spike protein, which is still mutating, should be more resistant to new variants like Omicron.
According to the two companies, preliminary laboratory results support this hypothesis.
The Pfizer pill is a combination of two pills taken twice a day for five days. This pill may be given to high risk patients aged 12 years and over.
Merck’s treatment, called molnupiravir, is given with eight doses per day for five days. It has already been licensed in the UK and Denmark.
It works by entering the genome of the virus to cause mutations that limit its reproduction.
While clinical trials have not detected any major risks to patients for the two drugs, Merck’s drug was of greater concern.
Not for under 18s and pregnant women
The United States Medicines Agency has not approved the Merck pill for anyone under the age of 18 because it could affect bone and cartilage development.
It is also not recommended for pregnant women, due to the potential risk to the fetus, but doctors can ignore it if the benefits outweigh the risks.
Preliminary results, which only took into account a portion of the trial participants, had initially advanced a 50% reduction in the rate of hospitalization and death in patients at risk, a figure ultimately reduced to 30 % on full results.
The United States bought 3.1 million Merck treatments and 10 million from Pfizer.
The country faces, two days before Christmas, the rapid advance of the Omicron variant, now the majority in the United States.