日本国内首个新冠口服药即将上市，Shionogi公司正为之努力

Introduction: Shionogi Company submitted a new drug application requesting conditional early approval for Japan’s first domestic COVID-19 oral drug.

On February 25, 2022, Shionogi & Co submitted an application for conditional early approval of Japan's first domestic COVID-19 oral drug. The Japanese government hopes that the oral drug can become a "trump card" in preventing serious diseases and ending the long-term pandemic.

If officially approved, Shionogi's experimental drug would become the third oral antiviral drug approved in Japan to treat mild symptoms of COVID-19, following Merck & Co.'s molnupiravir (monupiravir) and Pfizer's Paxlovid.

(Source: japantimes.)

Dr. Takeshi Urano, a professor of pathochemistry at Shimane University School of Medicine, said the oral drug, which can be used to treat mild symptoms, could be a game-changer in the long-term fight against the coronavirus.

Experts say Shionogi's drug may have high potential because it targets the same enzyme (3CL protease) as Pfizer's oral drug, which plays an important role in viral replication of various coronaviruses. Paxlovid, taken within three days of symptom onset, was 89% effective in preventing hospitalization and death in high-risk adults.

By contrast, Monupiravir, originally developed by Merck to treat influenza, works against various viruses by disrupting ribonucleic acid (RNA) polymerase, an enzyme that viruses use to replicate themselves. The drug integrates RNA-like building blocks into the coronavirus's genome and causes a series of errors that make it more difficult for the virus to replicate. In clinical trials, monopiravir reduced the risk of hospitalization or death by 30%.

"Paxlovid is a combination drug consisting of ritonavir; [used to treat AIDS for decades]) and nirmatrelvir, and Shionogi's drug is a newly discovered treatment," said Dr. Masahiro Kami, executive director of the Tokyo Institute of Medical Governance.

Pfizer's Paxlovid is a sensitive drug compared to Shionogi's oral version, Kami said, because doctors must carefully review what medications patients are now taking to avoid harmful drug interactions.

"For example, the manual says to reduce the dose of Paxlovid for patients with poor kidney function, but it is difficult to prescribe it. In that sense, Shionogi's oral version is easier to use," he said.

Shionogi's drug, developed in collaboration with Hokkaido University, has been shown to have high antiviral activity against the omicron variant (like other variants).

The company said that in a mid-term clinical trial of 428 patients with new coronavirus pneumonia, the drug achieved significant and rapid antiviral effects, and submitted an application on the 25th. The trial results showed that the drug did not show a significant difference in treating all symptoms compared to placebo, but it was shown to have a significant improvement in respiratory symptoms such as nasal congestion, sore throat, cough and shortness of breath.

Kami said Shionogi's and Pfizer's drugs have the same mechanism, which could mean one will have a longer-lasting effect than the other.

He said: "We still need to collect a lot of clinical data. It doesn't matter which of the two drugs is better. In terms of the number of clinical trials, there is a big difference. Pfizer responded quickly and has already conducted clinical trials for patients with poor liver and kidney function. At the same time, Shionogi has not even completed its first large-scale clinical trial. In this sense, Shionogi is at a disadvantage."

We hope that Shionogi’s oral COVID-19 drug will be launched soon and change the rules of the game in the long-term pandemic.

References:

https://www.japantimes.co.jp/news/2022/02/25/national/science-health/shionogi-pill-approval-application/