BUSINESS: Coronavirus (COVID-19), Update: FDA Authorizes The First Oral Antiviral To Treat COVID-19

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SILVER SPRING, Md. , Dec. 22, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA encourages everyone to get vaccinated. Learn more about FDA-approved or -authorized COVID-19 vaccines.

Paxlovid consists nirmatrelvir which inhibits a SARS-2 protein to prevent the virus from reproducing, and ritonavir which slows down nirmatrelvir’s breakdown to allow it to remain in the body for a longer time at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid cannot be used for more than five consecutive days.

An EUA is not the same as an FDA approval. The FDA carefully weighs all scientific evidence and balances known or potential risks against any potential benefits. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Paxlovid may be effective for the treatment of mild-to-moderate COVID-19 in authorized patients. Paxlovid’s potential benefits outweigh its potential risks when used in accordance with the authorization terms. There are no adequate, approved and available alternatives to Paxlovid for the treatment of COVID-19.

The primary data supporting the EUA for Paxlovid come from EPIC-HR. This trial was a double-blind, placebo controlled clinical trial that evaluated Paxlovid in non-hospitalized patients with confirmed SARS-CoV-2 infections. Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due to any cause during 28 days of follow-up. Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 1,039 patients had received Paxlovid, and 1,046 patients had received placebo and among these patients, 0.8% who received Paxlovid were hospitalized or died during 28 days of follow-up compared to 6% of the patients who received placebo. The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated. Possible side effects include diarrhea, high blood pressure, and muscle aches. Paxlovid may interact with other drugs, which could lead to serious drug interactions. HIV-1 drug resistance may develop in those with undiagnosed or uncontrolled HIV-1 infection. Ritonavir can cause liver damage. Patients with liver disease, liver enzyme abnormalities, or inflammation should not be given Paxlovid.

Because Paxlovid inhibits a group enzymes that breaks down certain drugs, it is contraindicated for certain drugs that are heavily dependent on these enzymes and are at risk of serious or life-threatening reactions. Paxlovid should not be used in conjunction with drugs that induce these enzymes. This will cause Paxlovid to break down nirmatrelvir and ritonavir faster. In turn, this may lead to a loss of virologic response or the development of viral resistance. Paxlovid should not be taken immediately after stopping any of these medications. The effects of the medications will remain even after discontinuation. For a complete list of drugs that should not be taken in combination with Paxlovid, see the fact sheet for healthcare providers.

Paxlovid should not be used in patients with severe renal or severe liver impairment. Patients with moderate renal impairment may need to take a lower dose of Paxlovid. Paxlovid should not be prescribed to patients with liver or kidney problems.

Under the EUA, fact sheets that provide important information about using Paxlovid in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers. These fact sheets contain information on how to use Paxlovid, side effects and interactions, as well as who can prescribe it.

Additional Resources:

Paxlovid EUA Letter of Authorization
Frequently Asked Questions on the Emergency Use Authorization for Paxlovid
Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
Coronavirus Disease (COVID-19)
Coronavirus Treatment Acceleration Program (CTAP)

Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer Inquiries: Email or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 1878580Consumer Inquiries:

SOURCE U.S. Food and Drug Administration

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