By Sy Mukherjee
June 28, 2018

The Food and Drug Administration (FDA) has given an experimental, single dose flu drug from Genentech a priority review, meaning the treatment could theoretically be approved by the end of 2018 and hit the market ahead of next year’s flu season.

Genentech, an independent arm of the Swiss drug giant Roche, announced the FDA priority review for baloxavir marboxil in a press release. The company noted that baloxavir marboxil has a different action mechanism from most flu drugs. Furthermore, it’s a treatment that’s taken by mouth and could theoretically be used by anyone 12 years of age or older who contracts acute flu (without added complications).

“The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years,” said Genentech chief medical officer Dr. Sandra Horning in a statement.

The experimental treatment can tackle various flu varieties such as H7N9 and H5N1, according to Genentech, and behaves in a different way from other antivirals. The drug targets a protein that’s critical for the replication of the influenza virus itself.

This past year’s flu season was a particularly brutal one, as the H3N2 virus strain floating around wreaked particular havoc and was relatively immune to vaccines. Public health officials have to play a guessing game when concocting massive stores of the flu shot; it can be difficult to gauge which strains in particular will dominate in a given flu season, making the prospect of new drugs to treat the infection imperative.

There are also efforts underway to develop a universal flu vaccine that can immunize against the lion’s share of strains, including one sponsored by the Bill & Melinda Gates Foundation.

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