New drug approved for the flu virus in 20 years

Updated: Jun 20, 2021

Influenza (flu) is a highly contagious airborne disease that is transmitted by the influenza virus. It occurs seasonally in the United States and responsible for thousands of deaths every year. According to the United States Center for Disease Control, nearly 50 million Americans were sick and close to 79,000 people died from the influenza virus and complications during 2017/2018 flu season. Antivirals are typically prescribed to patients who show symptoms of the disease (fever, body ache, cough, sinus congestion etc). The U.S Food and Drug Administration has approved Xoflusa (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu virus) in patients who are 12 years of age and older and has been symptomatic for 48 hours or less. (10/24/2018).




At some point during recent flu seasons, there were periods of supply shortages of the currently available FDA approved medications for the flu. “With thousands of people getting the flu every year and many people becoming seriously ill, having safe and effective treatment alternatives is critical” said FDA Commissioner, Dr. Scott Gottlieb. This new medication will add to the pool of treatment options available and will be a better option for some patients who would prefer a once daily treatment.



Antiviral medications help reduce flu symptoms and shorten the usual course of flu-virus. “When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Dr. Debra Birnkrant, director of the FDA's Division of Antiviral Products Evaluation and Research.



According to the FDA, The safety and efficacy of Xofluza was demonstrated in 2 randomized clinical controlled trials of 1,832 patients. In both trials, patients treated with Xofluza had a shorter time to symptoms relief compared with patients who took placebo. In the second trial, there was no difference in the time to symptoms relief between subjects who received Xofluza and those who received another flu treatment.


It is important to note that along with other antiviral medications available to help shorten the course of influenza virus and lessen symptoms, they do not replace the yearly provided vaccination against influenza virus (flu).


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