Genentech Announces FDA’s Acceptance of sNDA for Xofluza (baloxavir marboxil) in Patients with Influenza

Shots:

• The sNDA application is based on P-III CAPSTONE-2 assessing Xofluza vs placebo & oseltamivir (75 mg) in 2,184 patients with high risk of complications from the influenza including asthma, chronic lung disease, morbid obesity or heart disease, aged > 12yrs.
• The P-III CAPSTONE-2 study results: reduction in improvement time of symptoms (74.6 hrs. vs 100.6 hrs & 101.6 hrs); time to resolve fever (30.8 hrs. vs 50.7 hrs.& 34.3 hrs.); incidence of complications (2.8% vs 10.4% & 4.6%); use of systemic antibiotics (3.4% vs 7.5% & 3.9%); viral shedding time (48 hrs. vs 96 hrs. & 96hrs.)
• Post FDA approval in Oct,2018, Roche’s Xofluza (qd, PO) is a novel antiviral drug active against oseltamivir-resistant strains and avian strains (H7N9, H5N1) and expect its FDA’s approval on sNDA by 4 Nov,2019

Click here to read full press release/ article | Ref: Genentech | Image: Pinterest