44. Xofluza


Active ingredient: baloxavir marboxil 
Disease: influenza 
Peak sales estimate: $1 billion 
Approved: Oct. 24 
Companies: Roche and Shionogi 

The scoop: Developed by Shionogi and licensed in by Roche’s Genentech, Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in about two decades. As Roche’s pharmaceuticals division chief Dan O'Day put it, the drug holds the potential as “a full replacement for Tamiflu,” whose sales have suffered since generics hit. With a convenient single dosage, Xofluza has showed it could alleviate flu symptoms as fast as Tamiflu, which requires twice-daily dosing for five days. It also boasts an advantage of faster cessation of viral shedding. The FDA currently approves the drug in uncomplicated flu, but Genentech is pursuing expansion into people at high risk of serious complications and already has positive phase 3 results to back its case. Roche is launching the drug at wholesale acquisition cost of $150 and expects peak sales of more than 1 billion Swiss francs ($1 billion). — Angus Liu

44. Xofluza

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