Roche Holding AG’s RHHBY member, Genentech announced that the FDA has accepted the supplemental new drug application (sNDA) for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications. The FDA is expected to make a decision on approval by Nov 4, 2019.
The sNDA was supported by results from the phase III CAPSTONE-2 study evaluating a single dose of Xofluza compared with placebo or Tamiflu,(oseltamivir) 75 mg, twice daily for five days, in people aged 12 years or older who are at high risk of complications from the flu. In the study, baloxavir marboxil met the primary and secondary endpoints compared to placebo. Baloxavir marboxil significantly reduced the duration of flu symptoms by more than one day. It also considerably reduced the duration of fever by nearly a day and the levels of virus in the nose and throat from 24 hours through 120 hours.
Xofluza would be the first antiviral medicine approved specifically for the high-risk population.
Xofluza will be further be evaluated in a phase III development program, including pediatric population, post-exposure prophylaxis and severely ill hospitalized people with influenza. The program will also assess the potential of the candidate to reduce transmission in otherwise healthy people.
Shares of Roche have increased 19.9% in the past year compared with the industry’s growth of 14%.
We remind investors that in January 2019 the FDA approved the 0.5mL dose of Sanofi’s SNY influenza vaccine, Fluzone Quadrivalent, for treating children falling within the six to 35-month age bracket. The 0.5 mL dosage is already approved for use in patients aged three years or older along with the lesser 0.25 mL dose, which is approved for kids in the six to 35-month age category. Both medicinal measures of the vaccine will be available for the upcoming 2019-2020 flu season.
Notably, in December 2018, the FDA approved Sanofi’s pediatric vaccine, Vaxelis, which is developed for active immunization to prevent six different diseases in minor patients aged six weeks to four years. Vaxelis has been jointly developed by Sanofi and Merck MRK. Both the companies are working on its production, with a commercial launch expected not before 2020.
Also, in January 2018, GlaxoSmithKline plc GSK received approval from the FDA’s Center for Biologics Evaluation and Research for the label expansion of influenza vaccine — Fluarix Quadrivalent. The vaccine has been approved for infants aged six months or older.
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