COVID-19: Chugai expands indications for antibody cocktail therapy: Lonapreve
October 11, 2021
Chugai:
-Antibody cocktail therapy, Lonapreve ™
With a new coronavirus infection,
We applied for expansion of indication as “preventive drug and therapeutic drug for asymptomatic infected persons”.
Monoclonal antibody
Lonapreve ™
Anti-SARS-CoV-2 monoclonal antibody “Lonapreve ™” [casilibimab / imdebimab]
“Prevention of COVID-19” and
For “treatment of asymptomatic infected people”
We are pleased to inform you that we have submitted an application for approval to expand the indication to the Ministry of Health, Labor and Welfare.
Subcutaneous administration addition:
In line with this expansion of adaptation
In addition to approved intravenous administration
We applied for additional usage to enable subcutaneous administration.
In this approval application, we would like to apply the special approval.
Application News Release | Chugai
https://www.chugai-pharm.co.jp/news/detail/20211011170001_1146.html
Chugai seeks expanded use of antibody cocktail
Chugai Pharmaceutical
on Monday asked Japan’s health ministry to greenlight the expanded use of a COVID-19 antibody cocktail.
The treatment
is currently authorized for use in patients with mild to moderate symptoms who are at risk of falling gravely ill.
Chugai, which has the exclusive rights to sell the drug in Japan,
wants it approved for use in people without symptoms and as a measure to prevent infection.
The cocktail of two virus-neutralizing antibodies is administered intravenously.
About 35,000 people in Japan
are believed to have undergone the treatment as of October 5.Chugai says a global clinical study has shown that
the drug reduced the risk of asymptomatic COVID-19 patients progressing to symptomatic by 31 percent.
The study also included family members who were not infected at the start of the trial and remained in close contact with the patients.
Chugai says the drug reduced their risk of symptomatic infection by 81 percent.
NHK WORLD-JAPAN News