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23NewsBulletin – Pfizer Inc. said on Tuesday that it is seeking US approval for its experimental antiviral Covid-19 pill, which reduces the risk of hospitalization or death in adults at risk of severe disease by 89% in a clinical trial.
The company's filing comes at a time when new infections are on the rise in the United States, driven primarily by hot spots in states where colder weather is driving more people indoors.
Pfizer's pill has been shown to significantly reduce hospitalizations and deaths among people infected with the coronavirus. The FDA is already reviewing a competing Merck pill, and several smaller drugmakers are expected to seek approval for their own antiviral pills in the coming months.
Pfizer announced earlier this month that its clinical trial found that taking the pill within three to five days of symptom onset reduced the risk of hospitalization and death by 85 to 89 percent in people with mild to moderate coronavirus infections.
Based on the promising results, independent experts advised that the company's study be halted.
If approved by the US Food and Drug Administration (FDA), the drug could provide patients with an effective way to treat themselves at home.
The only other FDA-approved COVID-19 treatments require an IV or injection administered by a health professional at a hospital or clinic.
"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world," said Albert Bourla, Pfizer's CEO, in a news release.
According to a Pfizer spokesperson, the data submitted by the company came from testing the medicine on unvaccinated, high-risk participants.
The FDA will make the final decision on who will be prescribed the drug and how it will be used.
The New York-based pharmaceutical company announced that it has begun the process of seeking approval for the treatment in several countries, including the United Kingdom, Australia, New Zealand, and South Korea, and that it intends to make additional international submissions.
Pfizer anticipates producing 180,000 treatment courses by the end of next month and at least 50 million courses by the end of 2022.
Vaccination, according to health officials, will continue to be the best way to protect against COVID-19 infection.
Before making a decision, FDA regulators will examine company data on the safety and effectiveness of the drug, which will be called Paxlovid.
Earlier on Tuesday, the company announced that, through a licensing agreement with the international public health group Medicines Patent Pool, it will allow generic manufacturers to supply its Covid-19 pill to 95 low- and middle-income countries (MPP).