The FDA granted priority review to Genentech’s influenza drug candidate baloxavir marboxil.
The candidate would be the first new flu drug to hit the U.S. market with a new mechanism of action in two decades. The agency is expected to make a decision on approval by the end of 2018.
Roche executives said the FDA based the priority review decision on clinical trials that showed it decreases symptom duration and viral shedding. The drug is already approved for use in Japan.