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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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