COVID-19:台湾、アビガンの備蓄を決定:Centers for Disease Control、R.O.C(動画):
COVID-19:Taiwan’s government organization decides to stockpile Fujifilm’s Avigan® :
COVID-19:台湾政府组织决定储备富士胶片的抗流感药物“Avigan®Tablet”
—富士フイルムが台湾にAvigan®Tabletを供給—
富士フイルム:
7月13日、抗インフルエンザ薬Avigan®Tablet 200mg(Favipiravir)の台湾政府機関へ発送します。
Centers for Disease Control、R.O.C.(感染症対策担当)が、Avigan Tabletの備蓄を決定しました。
Centers for Disease Control、R.O.C:
台湾でのヒト伝染の可能性が高まっていることから、鳥インフルエンザ/豚インフルエンザ/新型インフルエンザのリスクから、台湾国民を保護することを決定しました。
台湾:食品医薬品局
食品医薬品局は、現在、アビガンの製造/販売を、まだ承認していません。
一方、台湾のCDCは、その新しい作用機序やその他の利点を認めて、例外的に実験薬の輸入を決定しました。
日本:フェーズIII臨床試験
アビガンタブレットは、2014年3月に日本での製造販売が承認された抗インフルエンザ薬です。
日本でのフェーズIII臨床試験では、台湾のサンプルを対象とした国際共同試験も、含まれています。
既存の抗インフルエンザ薬:
ノイラミニダーゼ阻害剤で、増殖したウイルス粒子の放出をブロックして感染の拡大を防ぐように設計されています。
対照的に、Avigan Tablet:
異なる作用機序を持つウイルスRNAポリメラーゼ阻害剤で、細胞内でのウイルスの遺伝子複製を、阻止して増殖を防ぎます。
このメカニズムにより、Avigan Tabletは、さまざまな鳥インフルエンザウイルスに対する抗ウイルス効果が期待されています。
富士フイルム:
富士フイルムは、「台湾のCDCが医薬品を備蓄することを決定したこと」を受けて、Avigan Tabletを提供しました。
Avigan Tabletが備蓄目的で供給されるのはこれが初めてです。
Standard Chem. & Pharma. Co., Ltd.: (CEO: Roy Fan)
Avigan Tabletは、台湾の大手製薬会社を通じて患者に供給されます。
台湾のCDCからAvigan Tabletの輸入を委託されています。
Taiwan’s government organization decides to stockpile Fujifilm’s anti-influenza drug “Avigan® Tablet”
—Fujifilm supplies Avigan® Tablet to Taiwan—
FUJIFILM Corporation
has announced that it provided, on July 13,
a shipment of the anti-influenza drug Avigan® Tablet 200mg (Favipiravir, hereinafter “Avigan Tablet”) to Taiwan’s government organization
in charge of infectious disease control, called the Centers for Disease Control, R.O.C. (Taiwan) (hereinafter “Taiwanese CDC”), following its decision to stockpile Avigan Tablet.
The Taiwanese CDC
made the decision to protect Taiwanese citizens from the risk of new strains of influenza including avian and swine influenzas due to a growing possibility of its human transmission in Taiwan.
Taiwan’s Food and Drug Administration
has yet to approve the manufacturing and marketing of Avigan Tablet at this stage,
but the Taiwanese CDC has decided the import of the experimental drug exceptionally in recognition of its new mechanism of action and other benefits.
Avigan Tablet, created by the Fujifilm Group company Toyama Chemical Co., Ltd.,
is an anti-influenza drug approved for manufacturing and marketing in Japan in March 2014. Its Phase III clinical trial in Japan included an international joint trial that involved samples in Taiwan.
Influenza viruses replicate their genes within infected cells to propagate and release new viral particles and to spread the infection to other cells.
Existing anti-influenza drugs
are Neuraminidase inhibitors, designed to block the release of propagated viral particles so as to prevent the spread of infection.
In contrast, Avigan Tablet
is a viral RNA polymerase inhibitor with a different mechanism of action, blocking viruses’ gene replication in cells to prevent their propagation.
Due to this mechanism, Avigan Tablet
is expected to have anti-viral effects on a variety of avian influenza viruses. Its efficacy has already been confirmed in animal testing.
In most cases, avian or swine influenza viruses do not infect humans.
However, when it has infected humans, there is a concern that they could combine with regular seasonal influenza viruses (e.g. H1N1) and mutate into a new strain capable of human infection, triggering a pandemic.
In the given circumstance, Fujifilm
has supplied Avigan Tablet in response to the Taiwanese CDC’s decision to stockpile the drug.
This is the first time Avigan Tablet is supplied for stockpiling purposes.
The supplied Avigan Tablet
is to be used on people who become infected with a new strain of influenza including avian and swine influenzas.
In the case of administration, the data will be provided to Fujifilm.
The drug will be supplied to patients via Taiwan’s major pharmaceutical company,
Standard Chem. & Pharma. Co., Ltd. (CEO: Roy Fan),
which is commissioned by the Taiwanese CDC to import Avigan Tablet.
In partnership with Standard Chem. & Pharma.,
Fujifilm will work toward the drug’s manufacturing and marketing approval in Taiwan at an early stage.