💊 Roche & Medicines Patent Pool Expand Access to Influenza Treatment 🌍
Roche and Medicines Patent Pool have signed a licensing agreement to expand access to the influenza antiviral drug Xofluza across 129 low- and middle-income countries.
The partnership will support affordable generic production, improve outbreak preparedness, and strengthen global healthcare access.
✔️ WHO-recommended treatment
✔️ Expanded access in 129 countries
✔️ Stronger pandemic preparedness
This flu season has been rough. Antivirals can help.
Antiviral drugs for influenza, the best known of which is Tamiflu, are—let’s be honest—not exactly miracle cures. They marginally shorten the course of illness, especially if taken within the first 48 hours. But amid possibly the worst flu season in 25 years, driven by a variant imperfectly matched to the vaccine, these underused drugs can make a bout of flu a little less miserable. So consider an antiviral. And specifically, consider Xofluza, a lesser-known drug that is in fact better than Tamiflu.
The culprit behind this awful flu season is subclade K, a variant of H3N2 discovered too late to be incorporated into this year’s flu vaccine. Early data suggest the shot likely does confer at least some protection against this variant, but the jury is still out on whether that protection is much eroded from usual. What is undeniable, though, is a recent explosion of influenza cases. In New York, which was hit early and hard, the number of people hospitalized for flu broke records. Across the rest of the country, cases have been going up a “straight line,” nearly everywhere all at once, which is highly unusual, Arnold Monto, an epidemiologist at the University of Michigan who has been studying influenza for some 60 years, told me last week. Cases seem to be finally leveling off now, but much misery still lies ahead.
For flu, antivirals are a second but oft-overlooked line of defense after vaccines. “We are dramatically and drastically underutilizing influenza antivirals,” Janet Englund, a pediatric-infectious-disease specialist at the University of Washington, told me. Even the older, more commonly prescribed drug Tamiflu reaches only a tiny percentage of flu patients every year. Actual numbers are hard to come by, but compare the estimated 1.2 million prescriptions for Tamiflu and its generic form in 2023 with the some 40 million people who likely got the flu in the winter of 2023–24. Xofluza is even less popular, and exact prescription numbers even harder to find. But they are possibly somewhere from just 1 to 10 percent that of Tamiflu.
The two antivirals are equally effective at allaying symptoms, both shortening the duration of flu by about a day. But Xofluza, which was approved in 2018, offers some tangible benefits over Tamiflu.
First, Xofluza is simply more convenient, a single dose compared with Tamiflu’s 10, which are taken over five days, twice a day. It also causes fewer of the gastrointestinal side effects, such as vomiting and nausea, that patients on Tamiflu will sometimes experience. All in all, a course of Xofluza might be easier for you—or your kid already queasy from the flu itself—to get down and keep down. (That is, if they are old enough to take it: Xofluza is approved for kids ages 5 and up in the United States, but ages 1 and up in Europe; only Tamiflu is recommended for kids down to newborn age as well as for women who are pregnant or breastfeeding.)
Second, Xofluza makes you less contagious to the rest of your family. It drives down the amount of virus spewed by sick patients more quickly than Tamiflu, possibly because of differences in how the two drugs work. Whereas Xofluza stops the virus from replicating, Tamiflu can only prevent already replicated viruses from exiting infected cells to infect others. In a study that Monto led last year, Xofluza cut household transmission by almost one-third compared with a placebo. Tamiflu might reduce transmission too, according to other studies, but probably to a lesser degree than Xofluza.
Third, Xofluza is better at heading off serious post-flu complications such as pneumonia or myocarditis. Patients on Xofluza needed fewer ER visits and hospitalizations than did those on Tamiflu, according to studies of large real-world data sets from insurance claims and medical records. This means that Xofluza should be the antiviral of choice for high-risk patients, including those over 65, who are most prone to these complications, Frederick Hayden, a flu expert at the University of Virginia who led one of the original Xofluza trials, told me. (Hayden has consulted on an unpaid basis, aside from travel expenses, for the companies behind Xofluza.)
The fourth advantage is less relevant to this season because the dominant subclade belongs to the influenza A family. But Xofluza is noticeably more effective against influenza B than Tamiflu, which tends to falter against this family of viruses.
Despite these benefits, awareness of Xofluza remains low. “It hasn’t been used as much as it should be,” Monto said, for reasons of cost and accessibility. Tamiflu, first approved in 1999, is available as a generic for less than $30 even without insurance. Xofluza is still patented and runs $150 to $200 a person. Because it’s less popular, pharmacies are less likely to stock it, making doctors less eager to prescribe it, and so on. In October, though, the company that markets Xofluza in the U.S. launched a direct-to-customer program that sells the drug for the comparably bargain price of $50 without insurance, along with same-day delivery in some areas. Even the flu-drug experts I spoke with, though, were not all aware of this new, more accessible route. The CDC still lists Tamiflu first and foremost in its recommendations, too.
For flu antivirals to be more widely used would also require better testing. Both Xofluza and Tamiflu are most effective within the first 48 hours of symptoms, and the earlier the better. Traditionally, a sick person would have to get to a doctor, get a flu test, get a prescription, and finally get to a pharmacy—which can easily put them past the first 48 hours. But COVID popularized at-home rapid testing, and combination COVID-flu tests have landed on pharmacies shelves recently. With telehealth and home delivery, you can get an antiviral without ever leaving the house.
Still, the at-home tests are expensive, Englund pointed out, about $20 a pop here, compared with just a couple of bucks in Europe. The expense can add up for a whole family. In Japan, where antivirals are widely used, nearly everyone with a flu-like illness gets a routine rapid test and, if necessary, antivirals, both largely covered by the public health-care system. (Xofluza was developed by the Japanese company Shionogi, which also makes Xocova, a promising COVID antiviral my colleague Rachel Gutman-Wei has written about that is not available in the U.S.)
If the U.S. were better at using antivirals, especially in the high-risk patients, the number of Americans dying of flu—roughly 38,000 last year—would likely drop, Cameron Wolfe, an infectious-diseases expert at Duke, told me. Doctors recommend that people at high risk for flu take antivirals prophylactically, upon exposure to anyone with flu, before symptoms appear. Both Xocova and Tamiflu as prophylaxis can cut the chances of getting sick by upwards of 80 percent.
For healthy people who fall ill, antivirals can ease the burden of flu, which is nasty even when it is not deadly. “I don’t want you to be out of work longer than you need to be. I don’t want you to not be a caregiver for your kids,” Wolfe said. “Maybe you have business travel coming up, and I don’t want you to be sick still on that plane.” With challenges around access to antivirals, he said that “the best drug is the one you can get.” Both Tamiflu and Xofluza can make this historically bad flu season a little more bearable.
FDA Accepts Genentech’s NDA for Xofluza for Flu Treatment in Children
MedicalResearch.com: What are the applicable pediatric and post-exposure indications?
Response: We recently announced that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours.
The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation.
MedicalResearch.com: What is the background for and main findings of the underlying studies? How does Xofluza® differ from other drugs for flu treatment or prevention?
Response: These filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.
The miniSTONE-2 study evaluated the safety, pharmacokinetics and efficacy of single-dose, oral suspension Xofluza compared with oseltamivir in otherwise healthy children aged one to less than 12 years of age with influenza. The median time to alleviation of signs and symptoms in influenza-infected participants was 138 hours (95% CI: 117, 163) and 150 hours (95% CI: 115, 166) for those who received Xofluza or oseltamivir, respectively. Xofluza was well tolerated, with no safety signals identified.
BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone who had been diagnosed with influenza. The proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza compared to those treated with placebo (proportion of subjects with influenza virus infection, fever and other flu symptoms in the 10-day observation period: 2% versus 14%, p
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Influenza viruses with resistant to the newest drug
Doctors in Japan began using a new flu drug called Xofluza since March 2018. According to the creators of medication, it's able to overcome the disease in the shortest time. The drug was also approved for sale in other countries, for example, in the United States.
Baloxavir marboxyl is the active ingredient of the new remedy. Many experts found Xofluza a real breakthrough in pharmacology. Its principle of action was different from other flu drugs. It was also important that patient could take only one dose of the remedy. This made the medication much more convenient than the analogues on the market. The drug reduced the duration of the disease and the severity of the symptoms, alleviating the condition of the patients.
Not only the scientific and patient community responded to the appearance of the new drug. Researchers from Japan have discovered influenza viruses in recent months, whose strains have resistance to Xofluza. Scientists noted, mutated influenza viruses that were not affected by baloxavir marboxyl were found in about one in four (about 23.4%) of the study participants, which they examined. Researchers examined schoolchildren - children under the age of 12 years. The discovered strains were 120 times more resistant to the new drug, than influenza viruses without mutations.
The USFDA approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
This is the first newly antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.
This is the first newly antiviral flu treatment with a novel mechanism of action…
FDA approves a new drug Xofluza (baloxavir marboxil) to treat influenza
FDA approves a new drug Xofluza (baloxavir marboxil) to treat influenza
FDA approves a new drug to treat influenza
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Continue reading… https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm?utm_campaign…
