Roche’s new, single-dose flu drug gets the green light at a hard charging FDA, breaking into record-setting territory

Roche got the first new landmark drug approval we’ve seen in flu for 20 years — while setting a record on new drug approvals for the same period.

The agency gave a thumbs up to baloxavir marboxil for flu, which Roche proudly hailed as the first one-dose dose of a drug that can help deal with flu misery. The pharma giant now plans to roll it out as Xofluza, in plenty of time for the flu season ahead.

Sandra Horning

“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,” says Genentech CMO Sandra Horning.

Roche needs this one to counter the arrival of cheap Tamiflu generics, but it may prove easier to get this therapy through the regulators at FDA than it will be with payers. While Roche’s drug handily beat out placebos, they weren’t so good against Tamiflu in the head-to-head. As the pharma giant notes, their new drug and the old one registered exactly the same in the duration of symptoms: 54 hours.

And while patients may like some added convenience, don’t expect payers to pass up on deep discounts for generics. They’ve proven far more interested in cost than convenience. Yet Roche did have some good news for a subpopulation, with their drug beating Tamiflu in the influenza subtype B category, with a median time to improvement of 74.6 hours compared to Tamiflu’s 101.6 hours (p<0.05). Their drug also reduced “the time that the virus continued to be released from the body (viral shedding; median time of 48.0 hours for baloxavir marboxil versus 96.0 hours for both placebo and oseltamivir; p<0.0001).”

We still need a few more new OKs to get past the all-time drug approval high at the FDA, but that would seem an easy task for an agency bent on accelerating OKs for drugs that can pass muster with regulators. 

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Director Process Development
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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