FDA Expands the Approval Indication for Influenza Treatment to Post- Exposure Prevention

The U.S. Food and Drug Administration (US FDA) expanded the approved indication for baloxavir marboxil on 23rd Nov'20. FDA included post exposure prevention of influenza (flu) for patients 12 years of age and older after a contact with an individual suffering from flu as an expanded indication. Baloxavir marboxil was previously available only as a tablet, but now it is also available as granules for mixing in water.

Baloxavir marboxil was approved in 2018 for treating uncomplicated flu in patients of 12 years and above who have been symptomatic for not more than 48 hours.

‘US FDA expanded the approved indication for baloxavir marboxil to post- exposure prevention. Baloxavir marboxil was previously available only as a tablet, but now it is also available as granules for mixing in water.’

Flu is a contagious respiratory illness caused by the influenza viruses. If the influenza patients are started on antiviral drugs within 48 hours of becoming sick, it can reduce symptoms and duration of illness. Taking an annual seasonal flu vaccine is the best way to protect against flu.

Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research said, "This expanded indication for Xofluza (Baloxavir marboxil) will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic. Americans will have to be more vigilant than ever as these viruses spread concurrently."

The efficacy of Baloxavir marboxil was studied through a randomized, double- blind, controlled trial which consisted of 607 participants. The participants were above 12 years of age and were exposed to a person with influenza in their household.

The patients received either a single dose of baloxavir marboxil or a single dose of placebo (no drug). Out of the 607 subjects, 303 received baloxavir marboxil and 304 received the placebo. The trial's endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Only 1 % of participants who received the drug met these criteria compared to 13 % patients in the placebo.

The most common side effects of baloxavir marboxil are diarrhoea, bronchitis, nausea, sinusitis and headache.

Hypersensitivity ( undesirable effects/ allergies) can occur in patients taking Baloxavir marboxil . Patient who have experienced a hypersensitivity to baloxavir marboxil should not consume this medicine. The medicine should not be co-administered with dairy products, calcium rich beverages and food items, antacids, laxatives or any oral supplements containing calcium, iron, magnesium, selenium, aluminium or zinc.

Source: Medindia