Roche’s New Flu Medication May Arrive Before Christmas
Xofluza Baloxavir Marboxil from Genentech Roche inhibits the cap-dependent endonuclease protein within the flu virus
The last flu season was unusually severe, especially on children, as the various flu viruses were constantly changing.
Although vaccines are an important first line of defense in preventing the flu, there is a significant need for new medical options for prophylaxis as well as treatment.
To meet this consumer demand, Genentech, a member of the Roche Group today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for Xofluza (baloxavir marboxil).
A Priority Review designation is good news for any new product.
This ‘fast-track’ status is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA is expected to make a decision on Xofluza’s (baloxavir marboxil) approval by December 24, 2018.
This new medication is a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older.
Xofluza (baloxavir marboxil) appears to be able to stop the flu infection in a few days and can be taken as a single dose.
The other flu medication most people might have heard about is Tamiflu, which is given as 2 pills a day, for 5 days.
“If approved, Xofluza (baloxavir marboxil) would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development, in a press release.
"First and foremost, it is important to remember that the best way to prevent the flu is to make sure you get a flu shot at the beginning of each flu season. This will give you the best fighting chance of not contracting influenza,” says Alexandria Duffield, Pharm.D. MTM Clinical Pharmacist and Immunization Specialist for Brookshire Grocery Company.
“However, if you do contract the flu, it is important for you to be educated about medications that can be taken to treat it, since taking these can lessen the time that flu symptoms are present, therefore preventing complications that can arise from the virus.”
"Currently, Tamiflu (oseltamivir), Relenza (zanamivir), and Rapivab (peramivir) are the only medications on the market for its treatment, but if Xofluza (baloxavir marboxil) is approved by the U.S. Food and Drug Administration, it will then be added to this list," Duffield said.
Xofluza (baloxavir marboxil) is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).
Unlike other currently available antiviral treatments, Xofluza (baloxavir marboxil) is designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.
The NDA is based on results from the Phase III CAPSTONE-1 study of a single dose of Xofluza (baloxavir marboxil) compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu.
This study found the following results:
- Xofluza (baloxavir marboxil) met its primary and secondary endpoints compared to placebo:
- Significantly reduced the duration of flu symptoms by more than one day (median time 53.7 hours versus 80.2 hours; p<0.0001);
- Significantly reduced the duration of fever by nearly a day (median time 24.5 hours versus 42.0 hours; p<0.0001);
- Significantly reduced the length of time viruses continued to be released from the body (median time of viral shedding; 24.0 hours versus 96.0 hours; p<0.0001);
- Significantly reduced the levels of virus in the nose and throat from 24 hours through 120 hours.
- Similar efficacy results were seen between Xofluza (baloxavir marboxil) and oseltamivir in relation to duration of symptoms and fever reduction, but significant differences were observed in time to cessation of viral shedding favoring Xofluza (baloxavir marboxil):
- No significant reduction in the duration of symptoms (median time 53.5 hours versus 53.8 hours; p=0.7560);
- No significant reduction in time to resolution of fever (median time 24.4 hours versus 24.0 hours; p=0.9225);
- Significantly reduced the length of time the virus continued to be released from the body (viral shedding; 24.0 hours versus 72.0 hours; p<0.0001);
- Significantly reduced the levels of virus in the nose and throat at 24 hours and 72 hours.
Additionally, Xofluza (baloxavir marboxil) was reported to be well-tolerated and had a numerically lower overall incidence of adverse events (20.7 percent) reported compared with placebo (24.6 percent) or oseltamivir (24.8 percent).
The most common adverse events reported were diarrhea (3.0 percent), bronchitis (2.6 percent), nausea (1.3 percent) and sinusitis (1.1 percent), and all of these adverse events occurred at a lower frequency than placebo.
Influenza, or flu, is one of the most common, yet serious, infectious diseases. Globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide.
Xofluza (baloxavir marboxil) was discovered by Shionogi & Co., Ltd. and is being developed globally by the Roche Group, which includes Genentech in the U.S.A., and Shionogi & Co., Ltd.
Genentech is a leading biotechnology company, is a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit here.
- FDA Grants Priority Review to Genentech’s Baloxavir Marboxil for the Treatment of Influenza
- A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
- Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
- One Dose, One Day: The Magic of Xofluza
- 2 Additional Pediatric Influenza-Related Deaths Reported, Total Reaches 171