Japan offers countless conveniences and pleasures that American consumers rely on on a daily basis. That is faster public transportation. Better sunscreen! Lychee Kit Kat! But one Japanese invention will be particularly welcome in the U.S. market as we head into disease season. It’s an antiviral drug that may shorten coronavirus symptoms and prevent chronic disease, and doesn’t taste like soapy grapefruit.
The drug encitervir, manufactured by Osaka-based pharmaceutical company Shionogi & Co., was conditionally approved in Japan last November. Like Paxlovid, ensitrelvir works by blocking an enzyme that the SARS-CoV-2 virus uses to clone itself in the human body. But the new drug will almost certainly not be available to the millions of Americans who are likely to become infected with the coronavirus in the coming months. In 2021, Pfizer was just waiting. 5 weeks Paxlovid to receive emergency use authorization. However, encitrevir remains in the approval pipeline, stuck in another clinical trial that could last until 2024.
existing data (Not all have been peer-reviewed) Studies show that people infected with the coronavirus who immediately took Enciterelvir, sold as Xocova in Japan, tested negative about 36 hours earlier than those who took a placebo. It has been. Fever, stuffy nose, sore throat, cough, and fatigue will also disappear about a day earlier.You may also lose your sense of smell and taste. solve Faster. The company also has some preliminary evidence suggesting the drug can help protect patients from developing long-term coronavirus infections.
Although these findings weren’t enough for the FDA, they were very encouraging, said Michael Lin, a bioengineering professor at Stanford University who works on developing treatments for coronavirus infections. Shokova “looked as good as Paxlovid, maybe a little better,” he says. For example, Pfizer’s clinical trial did not show that paxlobid resolved symptoms faster than a placebo in people who were not at high risk of developing severe COVID-19 infection. Shionogi & Co., Ltd. has achieved just that.
Reshma Ramachandran, a family physician at Yale University, told me that if the initial results with Zocova hold up in additional trials, she plans to prescribe Zocova to vaccinated patients instead of Paxlobid. Simply because the evidence supporting Zokova’s use is more direct. . She said she would especially like to donate to Zokova if the long-lasting coronavirus findings could be replicated.
No lab or drug company has yet published research pitting Zokova and Paxlobid against each other head-on in treating the coronavirus, so it’s impossible to say with certainty which one is better. No conclusion can be drawn just by comparing Pfizer’s clinical trial results and Shionogi’s clinical trial results. The company’s drug was tested at different points in the pandemic, when different variants were circulating, and in different populations with different levels of immunity. Shionogi also asked participants in its clinical trials to start taking Zocova within three days of feeling sick, while patients in the Paxrobid trial were given treatment up to five days after symptoms started. started. Daniel Griffin, an infectious disease expert at Columbia University, told me that antiviral drugs are all about timing. Generally, the sooner a patient starts taking a drug, the more effective the drug will be.
A Pfizer spokesperson told me that the efficacy and adverse event rates of paxlobid and Zocova cannot be directly compared, but emphasized the power of paxlobid to prevent hospitalization and death. (Xocova’s clinical trials failed to provide meaningful data on their results, which are now far rarer than in 2021.) As the world overcomes the challenges of COVID-19, ,” he said in an email.
Even if Xocova turns out to be less effective than Paxlovid, it still has some practical advantages. First, it literally makes it easier to swallow. Paxrobid must be taken twice a day for five days, and three tablets must be gulped down each time. Two of the tablets contain nilmatrevir (which actively fights the virus) and the other contains ritonavir (which slows nilmatrevir’s metabolism and keeps it in the body). longer). Xocova he only takes once a day for 5 days, and after taking his first 3 tablets, he takes 1 tablet at a time. Paxrobid can also cause taste disturbances, also known as paxrobid mouth, a sour, metallic taste that lasts for hours after swallowing. Xocova looks very tasty.
Experts expect Xocova to become more widely accessible than Paxlovid. Pfizer announced last week: price Once the drug hits the commercial market, Paxrobid’s price is expected to rise soon from $529 to $1,390. Shionogi has not determined the price of Xocova in the U.S. market, but there is reason to think it will be cheaper. In Japan, the only market where both drugs are currently available, a course of Xocova costs 51,851 yen (about $346), while Paxlobid costs nearly twice that at 99,027 yen (about $661). And while Japanese health authorities, like those in the U.S., recommend paxlobid for patients at high risk of severe COVID-19 infection, Zocova is effective for infected patients regardless of their risk status. It is shown. Finally, Paxlobid is limited in its scope by a number of adverse interactions with other drugs, whereas Zocova does not contain ritonavir, so it may be less problematic, Lin said. Told. The interaction profile of the new drug is still being determined, but a company spokesperson pointed out to me an ongoing issue. list Graduated from Liverpool University. (According to the source, you should avoid taking Paxlobid and Adderall at the same time, but it’s okay to take Zokova.)
Xocova may also avoid one of the concerns patients most commonly voice about paxlovid: that the coronavirus will come back after it subsides.Recent observations study In terms of the proportion of coronavirus patients, 19% of those who took Paxlobid experienced a recurrence of symptoms, compared to 7% of those who did not take Paxlobid. On the other hand, Shionogi & Co., Ltd. report In clinical trials of Xocova, symptom rebound rarely occurred.
Neither Shionogi nor the FDA would give me an estimate of the U.S. approval timeline for Xocova, but earlier this year the company’s CEO said: Estimation It could be approved in late 2024. The FDA approved the drug this spring. ”fast track“status. This means that once Xocova submits an application, it will be subject to an expedited review process. (The FDA declined to comment on Xocova’s approval prospects, citing federal disclosure laws.) Until then, the company plans to conduct further clinical trials in the U.S. and abroad. One of these will be conducted in collaboration with the National Institutes of Health and will evaluate the drug’s effectiveness in hospitalized patients. The other will evaluate its effectiveness against the new coronavirus, especially over the long term.
For some experts, Shokoba’s trucks aren’t fast enough. David Boulware, an infectious disease expert at the University of Minnesota, told me that the FDA appears to be “moving slowly” through the approval process. Lin is also looking forward to more action. But exactly how that happens is unclear. “I think the FDA is doing the best they can,” Ramachandran said. Given that the coronavirus public health emergency has ended, emergency use authorization for Xocova is not a realistic option. Additionally, Griffin said caution is needed when working with new drugs. “We want to make sure it’s safe. We want to make sure it’s effective,” he told me. “We also don’t want to fall into the trap we fell into with molnupiravir.” Molnupiravir, which initially seemed promising, ultimately had disappointing effects on COVID-19 patients (although , which was surprisingly useful for cats).
Even if the FDA approved Xocova tomorrow, demand for Paxlovid probably wouldn’t go away, experts told me. Lin said the two drugs, like Motrin and Aleve, could compete for users. People who are at risk of hospitalization or death from COVID-19 may still choose paxlobid. “But there’s a much larger group of people who don’t feel well and just want to feel better,” Griffin told me. Xocova might make more sense for them. You don’t have a choice until the FDA approves it.
