COVID-19：中外製薬が抗体カクテル療法で適応拡大：ロナプリーブ(動画）：
COVID-19:Chugai expands indication for antibody cocktail therapy:Lonapreve™
COVID-19：Chugai 扩大了抗体鸡尾酒疗法的适应症：Lonapreve™
2021年10月11日
中外製薬：
ー抗体カクテル療法・ロナプリーブー
新型コロナウイルス感染症で、
「予防薬および無症状感染者に対する治療薬」として、適応拡大申請した。
モノクローナル抗体
ロナプリーブ™抗SARS-CoV-2モノクローナル抗体「ロナプリーブ™」［カシリビマブ／イムデビマブ］
- 「COVID-19の予防」および、
- 「無症状感染者の治療」に対する、
適応拡大の承認申請を、厚生労働省に行いましたのでお知らせいたします。
皮下投与の用法追加：
- 本適応拡大に合わせて、
- 既承認の静脈内投与に加えて、
- 皮下投与を可能にする用法追加の申請をしました。
なお、今回の承認申請では、特例承認適用を希望しています。
申請ニュースリリース｜中外製薬
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