By KAI ICHINO/ Staff Writer
November 5, 2021 at 18:32 JST
Ronapreve, an antibody cocktail therapy authorized in Japan to be given to patients with no COVID-19 symptoms (Provided by Chugai Pharmaceutical Co.)
The health ministry gave fast-track approval on Nov. 5 for an antibody cocktail therapy, making it the first treatment in Japan authorized for people who have not developed COVID-19 symptoms.
Ronapreve has been administered to COVID-19 patients in Japan with mild and moderate symptoms through intravenous drips.
The ministry's decision came a day after the use of Ronapreve before the onset of the disease was approved by a ministry expert panel.
Chugai Pharmaceutical Co., which is in charge of the domestic sales of the drug, applied for approval in October for Ronapreve to be used to prevent COVID-19 symptoms from developing among asymptomatic patients and people who have come into close contact with infected individuals.
The Japanese pharmaceutical firm also sought authorization for administering the drug subcutaneously, under the skin.
Ronapreve combines two neutralizing antibodies that prevent the novel coronavirus from entering cells.
Recipients who have not developed symptoms must have a high risk of becoming seriously ill due to obesity or other underlying conditions. They also must have not been vaccinated against COVID-19 or have been unable to build up enough immunity against the virus through inoculation.
Ronapreve reduced the risk of developing COVID-19 symptoms by 81 percent among those who have come into close contact with patients in a clinical trial conducted in the United States and other countries, according to Chugai Pharmaceutical.
The clinical trial also showed asymptomatic patients who were given the drug were 31 percent less likely to develop symptoms.
When administered subcutaneously, Ronapreve needs to be injected into four sites under the skin on the recipient’s stomach, thighs and upper arms. The ministry will recommend the drug be given intravenously to treat patients with symptoms.
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