New anti-flu drug approved by FDA after 20 years

This year marked an exciting period in the field of medicine: the addition of another antiviral flu drug into the market. This follows the FDA‘s approval. Such an approval last occurred 20 years ago. This drug known as Xofluza (baloxavir marboxil) is used to treat flu infection before it becomes acute in the body. This drug is only applicable to persons above the age of 12 years who have experienced flu symptoms for a period not exceeding 48 hours. The FDA indicated that if this drug is taken prior to 48 hours after infection, it tends to lower the symptoms and the extent of sickness.

Approval of  Xofluza

Dr. Scott Gottlieb, who is the FDA chairman, said on Wednesday, October 24. 2018, that Xofluza is the first anti-flu drug that has a novel mechanism of action that the FDA has approved in nearly two decades. He also said that a drug that is not only safe and provides wonderful results is necessary so as to deal with the high rising cases of flu infections. He also commented that this drug will provide a treatment alternative.

His statement was applauded by another expert in this field. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, explained that Xofluza is quite different from other flu drugs such as oseltamivir or zanamivirin because it prevents the replication of the flu virus at an earlier period while these other drugs try to prevent the release of the virus which has already been produced by the host cell. He also explained this drug will lower the persistence of flu symptoms, such as muscle aches and fever, and therefore will help to reduce the possibility of contracting extreme complications such as pneumonia. He also stated this drug is quite easy to take, unlike other drugs which may require an intake of 2 doses for 5 days.

Studying of Xofluza

According to the FDA, prior to its approval, it was first tested against a placebo drug and another anti-flu drug. The study population consisted of more than 1800 flu sufferers; two clinical trials were carried out, and in the two trials, those patients who used Xofluza experienced symptoms diminishing compared to those who took a placebo. In the second trial, both Xofluza and other antiviral drugs lowered symptoms at the same rate. Bronchitis and diarrhea were the common side effects for patients who used Xofluza. Dr. Debra Birnkrant, the director for Center for Drug Evaluation and Research division for antiviral drugs argued that it is important to have more treatment alternatives that attack the virus in different ways since the flu virus can become resistant to antiviral drugs.

Flu prophylaxy

Dr. Gottlieb said that the various approved drugs should not be used as substitutes to vaccinate against the flu. Besides, the U.S. Centers for Disease Control and Prevention suggests that it will carry out flu tests before November.

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