The Food and Drug Administration (FDA) on Wednesday granted emergency authorization to Pfizer’s COVID-19 treatment pill, CNBC reported.
The medication, which is recommended for people at a high risk of developing severe COVID-19, could be available to patients as early as this weekend, according to the report. The Centers for Disease Control and Prevention is expected to quickly follow suit with its seal of approval, authorizing its distribution.
The FDA cleared the pill for patients 12 and up with mild to moderate COVID who are most likely to end up hospitalized or not survive. The agency said it should be prescribed as soon as possible after diagnosis and within five days of symptom onset.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” she added.
Pfizer submitted an application to the FDA for emergency authorization for its coronavirus drug last month.
The company says the drug, which is administered in a pill called Paxlovid, reduces the risk of hospitalization and death from the coronavirus by up to 90%.
President Joe Biden announced last month the US would buy 10 million courses of Pfizer's pill in a $5.3 billion deal which was contingent on the treatment's approval by the FDA.
Pfizer’s pill is the first oral antiviral drug authorized by the FDA that is specifically designed to fight COVID-19.
While the FDA said vaccines are the first line of defense against the virus, the drug provides a new tool in its fight against the virus.
Pfizer’s treatment is administered in two 150 milligram tablets along with a 100 milligram tablet of an HIV drug, ritonavir, twice daily. The HIV drug helps slow the patient’s metabolism, which allows Paxlovid to remain active in the body at a higher concentration for a longer period.
Another company, Merck, has contracted with the US government to supply at least 3 million courses of its pill, molnupiravir, which is still awaiting clearance, for $2.2 billion.
A study released in October found that the Merck poll cuts the risk of hospitalization or death from the illness in half.
In early November, Britain became the first country to officially authorize molnupiravir to treat coronavirus symptoms. Health Secretary Sajid Javid called the pill a "gamechanger" for patients with compromised immune systems.
Israel has expressed interest in purchasing the experimental drug.