Roche has taken another big stride toward gaining approval for its new flu therapy — eyeing a market launch just as winter is set to get serious.
We don’t have any data, but their second Phase III trial needed for a US OK has come through positive on the primary as well as several secondary endpoints. And the results come on top of its initial success, which laid the foundation for its regulatory package at the agency, slated to deliver an accelerated decision by Christmas Eve.
The drug is baloxavir marboxil, which Roche boasts is likely to be the first new MOA-thing in flu treatment in close to 20 years.
The primary endpoint in CAPSTONE-2 was a reduction in symptoms among the old or afflicted — asthma, heart failure, diabetes and so on — who were at high risk of complications or death.
CAPSTONE-1 offered data to support its primary endpoint on helping otherwise healthy people.
What’s the big idea here? Researchers have been working on the theory that blocking an enzyme critical for replication in a cell will stop the flu’s advance. And they are looking to replace Tamiflu’s 10-pill regimen with just 1 dose.
It will be interesting to see what they charge for this drug, if the approval happens as expected. Tackling the most clinically needy would help them in their quest in gaining coverage. On the other hand, Tamiflu is a generic now, and insurers tend to ignore things like the number of pills required if they can cut costs
Company officials have been bullish about this drug, especially as they’d like to replace the revenue being lost to cheap knockoffs of Tamiflu with a new branded drug revenue stream. They’ve talked up its ability to resolve the flu in 24 hours, versus 72 hours for Tamiflu, but the presence of a cheap generic has dragged back sales expectations.
The drug was discovered by Shionogi, which handled the trial work.
J&J, meanwhile, is working on pimodivir — in-licensed from Vertex — while another team concentrates on a universal flu vaccine, which remains one of the Holy Grails in R&D. J&J reported positive data from their mid-stage study last summer, with plans to hustle into a pivotal program of their own.
Shionogi already gained Japanese approval for their drug last February.
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