Pfizer asked U.S. regulators Tuesday for authorization to use its experimental pill. COVID-19This sets the stage for a possible launch of a home-based treatment, which is expected to be launched this winter.
The company’s filing comes as new infections continue to rise in the United States, mainly due to hot spots in states where it is colder and more Americans are staying indoors.
Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration has already begun to review a Merck-based competitor pill, and other smaller drugmakers will likely seek authorization for their antiviral medications in the coming months.
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Albert Bourla, CEO of Pfizer, stated that the company is working as fast as possible to get the potential treatment to patients and that it looks forward to working with the FDA to review our application.
Pfizer specifically wants the drug to be available to adults with mild-to-moderate COVID-19 infection and at risk of becoming severely ill. All FDA-authorized COVID-19 treatment require an IV or injection administered by a medical professional in a hospital or clinic.
The FDA will host a public meeting later in the month on the Merck Pill to hear the opinions of outsiders before making its final decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.
Experts predict that COVID-19 treatments may eventually be combined to provide better protection against the worst side effects of the virus.
Pfizer reported earlier in the month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company tested the pill on people who were not vaccinated or had health problems. If the FDA approves the use of the pill for breakthrough infections, it will have to weigh whether they are included in the initial testing.
For the best results, patients should begin taking the pills within three working days of symptom onset. This underscores the importance of prompt testing and diagnosis. If another COVID-19 surge causes testing delays or shortages, this could make it difficult.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. This is different from the Merck pill which causes tiny mutations in coronavirus to the point that it cannot reproduce.
Tuesday Pfizer has signed a deal with a U.N.-backed group Generic drugmakers will be able to make low-cost versions for certain countries. Merck has struck a similar deal for its Pill, which was approved in Britain earlier in the month.
The U.S. approved remdesivir, an antiviral medication for COVID-19, and three antibody therapies to aid the immune system in fighting the virus. They are usually administered by healthcare professionals and require time-consuming infusions. The supply was limited by the recent surge of the delta variant.
The U.S. government has already pledged to purchase Merck’s pill. According to a source familiar, federal authorities were in talks with Pfizer to purchase millions of doses of its pill.
Source: Fox News
