fdaoutsideweb

FDA expands approval of Genentech’s Xofluza for post-exposure prevention of influenza

pharmafile | November 24, 2020 | News story | Manufacturing and Production, Sales and Marketing FDA, Xofluza, influenza 

Genentech has secured FDA approval for Xofluza (baloxavir marboxil) for the post-exposure prevention of influenza in patients at least 12 years old. The decision makes it the first single-dose vaccine approved in the US to prevent flu infection after exposure.  

The FDA based its decision on the review of Phase 3 data published in The New England Journal of Medicine. The data showed that the proportion of participants who developed influenza following exposure in the household was 1% in the group that received a single dose of Xofluza, compared to 13% in those receiving the placebo. Genentech said this was evidence of a “statistically significant prophylactic effect”.

The therapy was found to be safe and tolerable, with only mild side-effects reported.

“The flu is a serious illness that burdens households and sickens millions across the US every year,” explained Serese Marotta, Chief Operating Officer at Families Fighting Flu. “As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”

Genentech confirmed it now plans to pursue a label expansion for the drug with the FDA, seeking approval to treat acute uncomplicated influenza in otherwise healthy children, as well as for the post-exposure prevention of influenza children between the ages of one and 12.

Matt Fellows

Related Content

Roche’s Alecensa approved by FDA as lung cancer treatment

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …

GSK’s meningococcal vaccine candidate accepted for FDA review

GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …

FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment

Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …

Latest content