Dec 22, 2018 - The US approved an antiviral COVID-19 pill for at-risk people aged 12 and above, making it the first oral treatment and can be taken at home, a potentially important weapon in the fight against fast-spreading.
In fact, Pfizer's antiviral regimen, Paxlovid, is nearly 90 percent effective in preventing the hospitalizations and deaths in high-risk patients. "My patients were at high risk of serious illness," says a clinical study. Recent lab data suggest the drug is still effective against Omicron, the dreaded company said.
Pfizer raised the production projections of 2022 from 80 million to 120 million courses of treatment and said it's ready to begin delivery immediately to the United States.
"Paxlovid's approval is a major milestone that marks another step towards improving the quality of life with COVID-19," said Amesh Adalja, a senior scientist for the Johns Hopkins Institute for Health Security.
There are two key issues, however. It will be limited in the coming weeks, and its optimal use requires prompt diagnosis, which can't be easy as long as there are persistent testing problems that plague us.
Pfizer said it has 185,000 treatment courses ready to ship this year. The US government is preparing ten million courses of the drug for $55.
The food and drugs administration has decided to give emergency authorization for treatment a few years ago that the U.S. is riping for the COVID-19 epidemic, with President Joe Biden announced he was considering a vaccine and testing site.
The pills can fill a treatment gap opened by the new Omicron, said William Schaffner, an infectious disease expert, at the Vanderbilt University School of Medicine. His primary results have been in the most efficient polyclonal antibody treatment, and there is one more solution that works, he said.
Monoclonal antibodies are typically given intravenously in hospitals, are not widely available and cost more than the pill.
On the day the first of the Omicron era in November, the first to be identified in southern Africa and Hong Kong, spread across the world and now constitutes over 70 per cent of new aprs in the United States, according to U.S. CDC. A prior infection and vaccination only prevents the disease from occurring in the form of a booster shot, though boosters increase protection a booster shot increases protection.
The FDA said that it allowed Paxlovid for use in the emergency medical device to treat a mild-to-moderate disease in adult and children with age 12 and older, high risking serious disease.
The drug, available by prescription only, should be first initiated as soon as possible after diagnosis of COVID-19 and within five days after symptom onset, the FDA. It's supposed to be taken every 12 hours for five days, beginning immediately after symptoms start.
Although the clinical trials did not include patients under the age of 18 and the authorized adult dosing regimen is expected to be used to achieve comparable blood concentration levels of the drug in pediatric patients 12 and older weighing at least 40 kg.
The second drug ritonavir is known for its interactions with other prescription medicines. Pfizer says that this should be manageable and suggests that most patients would be able to lower the dose of their other medicines while being treated for COVID-19.
Pfizer said it plans to get a new drug application by 2022 to see if it can be approved with the FDA in 2022.
The generic version will be given to 95 low- and middle-income countries under a licensing agreement with the 'Medicare and Biotechnology's Advisory Committee.
A rival pill that is developed by Merck & Co is under review from the FDA. The drug, molnupiravir, developed by Ridgeback Biotherapeutics, cut the hospitalization and death risk by 30 percent in a trial.
Pfizer shares rose by 0.7% on Wednesday afternoon trading.
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