FDA Approves First Oral Antiviral Drug to Treat COVID-19 in Adults

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Today, the U.S. Food and Drug Administration approved the oral antiviral drug paxlovid (nilmatrelvir and ritonavir tablets) for the treatment of mild to moderate COVID-19 in adults at high risk of severe disease progression. , packaged for oral use). COVID-19 (including hospitalization or death). Paxlovid is the fourth drug and first oral antiviral drug approved by the FDA to treat COVID-19 in adults.

Manufactured and packaged under an Emergency Use Authorization (EUA) and distributed by the U.S. Department of Health and Human Services, Paxlovid is available for adults aged 12-18 years without insurance coverage to ensure continued access. It remains available to ensure treatment for eligible children. With today’s approval. Paxlovid is not approved or approved for use as a pre-exposure or post-exposure prophylaxis for the prevention of novel coronavirus disease (COVID-19).

“While the pandemic is difficult for all of us, we have made great strides in mitigating the impact of COVID-19 on our lives,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. rice field. “Today’s approval confirms that paxlovid has met the agency’s stringent standards for safety and efficacy, and the risk of developing severe COVID-19, including those who were previously immune. FDA remains an important treatment option for people with high blood pressure.” FDA remains committed to working with sponsors to accelerate the development of new prevention and treatment options for COVID-19. do. ”

Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug requires, among other things, substantial evidence of efficacy and demonstration of safety for the drug’s intended use. When considering drug approval, the FDA conducts benefit-risk assessments based on rigorous scientific criteria to ensure that the benefits of the product outweigh the risks for the intended population.

The efficacy of Paxlovid was primarily supported by the final results of the EPIC-HR clinical trial. EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial investigating paxlobid for the treatment of nonhospitalized symptomatic adults with a laboratory-confirmed diagnosis of SARS-CoV-2 infection. rice field. Patients were adults aged 18 years or older with pre-specified risk factors for progression to severe disease or adults aged 60 years or older regardless of pre-specified chronic medical conditions. All patients had not been vaccinated against COVID-19 and had never been infected with COVID-19. Paxlovid was tested for any cause related to COVID-19 through 28 days of follow-up in patients who were treated within 5 days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibodies. It significantly reduced the rate of hospitalization or death by 86% compared to placebo. antibody therapy. In this analysis, 977 patients received paxlobid and 989 patients received placebo, and of these patients, during the 28-day follow-up, they were hospitalized for COVID-19 or had any 0.9% of patients died from any cause, compared with 6.5% of those who received paxlobid. Patients who received placebo.

The effect of paxlovid was observed in patients with previous immunity to the virus that causes novel coronavirus disease (COVID-19). Among patients with antibody-positive EPIC-HR at study entry, the risk of hospitalization or death from any cause related to COVID-19 during 28 days of follow-up was reduced in 490 patients treated with paxlovid 0.2% in patients treated with paxlovid compared with 1.7%. 479 patients who received placebo. EPIC-SR was another clinical trial enrolling vaccinated patients with at least one risk factor for progression to severe novel coronavirus disease (COVID-19). Although not statistically significant, the risk of COVID-19-related hospitalization and death from any cause was reduced among those vaccinated patients.

EPIC-HR and EPIC-SR are randomized controlled trials that provide information on COVID-19 rebound. Data from these two trials show that shedding of SARS-CoV-2 (RNA or virus) or rebound of COVID-19 symptoms occurred in some patients, and in paxlobid-treated patients versus placebo-treated patients. We showed that it happened on both. Based on the data currently available to the FDA, there is no clear link between paxlobid treatment and COVID-19 rebound.

Because of the importance of mitigating the risk of serious drug interactions with paxlobid, the EUA approved label for paxlobid and the approved fact sheet for health care providers include a boxed package containing instructions for prescribers. Comes with a warning. The prescriber should review all medications the patient has taken to assess potential drug interactions and may adjust, interrupt, and/or add additional medications to other medications the patient may be taking. You need to decide if monitoring is required. Prescribers should consider the benefits of paxlobid treatment in reducing hospitalizations and mortality and whether the risk of potential drug-drug interactions in individual patients can be adequately managed.

In connection with today’s approval, the FDA is providing all prescribers with information to help them properly and safely prescribe paxlobid, including dosage instructions, potential side effects, and information about drugs that may cause drug interactions with paxlobid. provides important information about The most common side effects from taking paxlobid include taste disturbance and diarrhea. Patients should discuss with their healthcare provider whether Paxlovid is right for them.

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FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and animal drugs, vaccines and other biological products for humans, and medical devices. is protecting The agency is also responsible for regulating our country’s food supply, cosmetics, dietary supplements, the safety and security of electronic radiation emitting products, and tobacco products.

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