Regulatory Competition for Merck and Pfizer as Covid-19 antiviral by...

Competition for Merck and Pfizer as Covid-19 antiviral by Shionogi gets the green light in Japan


As the battle against Covid-19 continues, regulators in Japan have given the go-ahead to the country’s very first Japanese antiviral. This was a win for Shionogi, a local drug manufacturer because it secured emergency approval for Xocova from MHLW (Japan’s Ministry of Health, Labor and Welfare) to be used against the SARS-CoV-2 virus. According to the company, this green light activates a supply contract for one million Xocova courses to be bought by the government of Japan.

Shionogi is a 144-year-old pharmaceutical company that operates out of Osaka, Japan. It is considered to be an expert in infectious diseases and invests significantly in its R&D. The primary focus of the company is to discover new drugs in-house, which is reflected by its original pipeline ratio.

According to Shionogi, this approval is the first for any drug under the country’s latest emergency regulatory approval system. The company is also aiming for its antiviral pill approval in the United States.

Katsunobu Kato, the Health Minister told reporters, “I expect it will contribute to coronavirus measures as another choice of treatment.” However, he mentioned that its use will not be allowed for pregnant women.

The emergency approval for Xocova was filed by Shionogi in Japan in February of this year. About five months later, the local health ministry demanded to see larger trial results as they thought the data provided by the company did not show sufficient improvement in the symptoms of the virus.

The latest approval for Xocova is based on results from mid-stage as well as late-stage components of the company’s phase II and III study conducted in Asia. In the latest data, which is from September, the drugs helped limit five of the symptoms of Omicron variant of Covid-19; cough, fever, runny or stuffy nose, tiredness or lack of energy, and sore throat. Xocova was able to bring these symptoms under control a full day quicker than the placebo. The drug is administered in pill form and is to be taken per day for five days.

With the help of emergency approval, the company is prioritizing the effective distribution of the drug. In the meantime, Shionogi will be pursuing the standard approval for the drug in its home country.

There will be big-name competition for the drug in the market as Merck’s antiviral drug called Lagevrio received the emergency green light in Japan last Christmas Eve. Also in the competition is Pfizer’s Paxlovid, which got authorization earlier this year in February.

Fujifilm, another Japanese firm that was working on the development of their antiviral called Avigan (or favipriavir) for the treatment of Covid-19, announced in October that it was backing down from the project. Fujifilm stated in a recent release that it halted enrollment in phase III Covid-19 trial of Avigan in March after, what they stated, were a change of circumstances that included the spread of Omicron as well as the improved rates of vaccination.

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