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Today, the US Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of uncomplicated acute influenza in patients 12 years of age and older with symptomatic symptoms for more than 48 hours.
"This is the first new antiviral treatment for influenza with a new mechanism of action approved by the FDA for nearly 20 years. With thousands of people becoming infected each year and many people becoming seriously ill, safe and effective substitution treatments are essential. This new drug is an important additional treatment option, "said FDA Commissioner Scott Gottlieb, MD" Although there are several FDA-approved antiviral drugs for treating the flu, they do not replace vaccination. annual. The flu season is already well advanced and the US Centers for Disease Control and Prevention recommend getting vaccinated by the end of October, as the seasonal flu vaccine is one of the most effective ways to get the flu shot. more effective and safer to protect yourself and your family and community. and serious complications related to influenza, which can lead to hospitalizations. Annual vaccination is the main means of preventing and controlling influenza epidemics. "
Influenza is a contagious respiratory disease caused by an influenza virus. Antiviral drugs can reduce the symptoms and duration of illness when flu patients are treated within 48 hours of their illness.
"When treatment is started within 48 hours after the onset of flu symptoms, antiviral drugs can alleviate symptoms and shorten times when patients feel sick," said Debra Birnkrant, MD, director of the Division of Antiviral Products of the FDA's Center for Drug Evaluation. Research. "It's important to have more treatment options that attack the virus in different ways because the flu virus can become resistant to antiviral drugs."
The safety and efficacy of Xofluza, an antiviral drug taken in a single oral dose, was demonstrated in two randomized controlled clinical trials in 1832 patients, in which participants were expected to receive either Xofluza, a placebo, or another antiviral treatment of influenza, within 48 hours following the administration of flu symptoms. In both trials, patients treated with Xofluza had less time to relieve their symptoms than patients taking placebo. In the second trial, there was no difference in symptom relief time between subjects who received Xofluza and those who received the other treatment for influenza.
The most common side effects seen in patients taking Xofluza were diarrhea and bronchitis.
The priority review was granted to Xofluza under which the FDA's goal is to respond to a request in a timely manner, when the agency believes that the drug, if approved, would significantly improve the safety or effectiveness of treatment, diagnosis or prevention of a serious problem.
The FDA has approved Xofluza for Shionogi & Co., Ltd.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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