The U.S. Food and Drug Administration has recently granted approval for new drug Xofluza (baloxavir marboxil) which would be used for treating flu. Reportedly, this is the first antiviral flu drug to be approved by FDA in almost 20 years.
According to the reports, a single oral dose of Xofluza will be used for treating uncomplicated flu in patients who are 12 years or older, exhibiting symptoms for no more than 48 ours. The antiviral drugs can reduce symptoms and illness duration when used within 48 hours of getting the flu, FDA had confirmed.
Dr. Scott Gottlieb, FDA Commissioner, said thousands of people get the flu every year and many of them become seriously ill, indicating the need for safe and effective treatment options. The new innovative drug provides a significant and additional treatment alternative, Dr. Gottlieb believes.
Unlike current medications available that only block virus releases already produced by a host cell, Xofluza acts to inhibit the replication of flu virus in the first place, stated Dr. Robert Glatter, a physician at New York City’s Lenox Hill Hospital. It could shorten the duration of fever and muscle aches, while also reducing chances of developing pneumonia or other downstream complications, he mentioned.
FDA informed that approval of the drug was based on the results of two clinical trials, comprising over 1,800 patients who were given either Xofluza, another antiviral flu treatment or a placebo within 48 hours of experiencing symptoms of the flu. In both the trials, Patients taking Xofluza had faster relief of symptoms than those who took the placebo and in the second trial, time taken for symptom relief was same for patients taking Xofluza and the other antiviral flu treatment.
Dr. Gottlieb added that even though many FDA-approved antiviral drugs for treating flu exist, they are not a substitute for yearly vaccination. For the record, the U.S. Centers for Disease Control and Prevention recommends that people get a flu shot before the end of October.