UK approves oral corona drug for mildly ill people: developed by US Merck & Co., etc.

Recently NHK news on-line reported the following:

コロナ飲み薬を英が承認　軽症者向け、米メルクなど開発

ヨーロッパ

2021年11月4日 20:24 (2021年11月5日 5:13更新)

坂田亮太郎さんの投稿

【ロンドン=佐竹実】英医薬品・医療製品規制庁（MHRA）は4日、米製薬大手メルクが新型コロナウイルス向けに開発した飲み薬を承認したと発表した。自宅で服用できる新型コロナの抗ウイルス薬の承認は世界で初めて。コロナ対策の切り札と期待されている。

MHRAが承認したのは、メルクが米新興リッジバック・バイオセラピューティクスと共同開発する「モルヌピラビル」。ウイルスの体内での増殖を抑える。MHRAによると、臨床試験（治験）では感染の初期段階で服用すると最も効果的だったという。検査で陽性となり、症状が出てから5日以内にできるだけ早く服用することを推奨している。

メルクによると重症化リスクのある軽度から中程度の症状のコロナ患者で、入院や死亡リスクを約50%低くする効果が治験で確認された。同社は2021年内に1000万回の治療にあたる量を生産する予定で、22年末までに世界8カ国にある自社工場で生産できるよう投資を進め、生産量を年間2000万回分に増やす。

日本の厚生労働省はモルヌピラビルについて、年内にも特例承認して国内で使用できるようメルクと調達協議を進めている。厚労省は米国など海外で使用許可が下り、国内で承認申請されれば審査を簡略化する特例承認の適用を想定する。

岸田文雄首相は1日の記者会見で「早期治療の切り札である飲み薬について年内実用化を目指し、承認された薬について必要量を確保する」と述べた。

英国は1日4万人程度の新規感染者が出ているが、死者や重症者が急増していないことからコロナと共生していく路線を変えていない。だが足元では入院患者数がやや増えており、冬に医療体制が逼迫する懸念もある。ジャビド保健相は4日、「英国にとって歴史的な日だ。モルヌピラビルをできるだけ早く患者に投与できるよう計画を立てている」とコメントした。

化合薬のモルヌピラビルは、ワクチンや抗体カクテル薬と比べて製造しやすい。メルクは10月、国連の関係機関がつくった非営利団体（NPO）「医薬品特許プール（MPP）」にモルヌピラビルの製造ライセンスを供与すると発表した。後発薬メーカーなどが途上国向けに安価に生産できるようになる。アフリカ諸国などワクチンの供給が遅れる地域では、重要な選択肢となる。

Translation

[London = Minoru Satake] The British Medicines and Healthcare Products Regulatory Agency (MHRA) announced on the 4th that it had approved a drug developed for the new coronavirus by Merck, a major US pharmaceutical company. This would be the world's first approval of a new corona antiviral drug that could be taken at home. It was expected to be a trump card to deal with the coronavirus.

MHRA had approved "Mornupiravir " that Merck jointly developed with the emerging US Ridgeback Biotherapy. It could suppress the growth of the virus in the body. According to MHRA, it was most effective in clinical trials when taken early in the infection. It was recommended to be take as soon as possible within 5 days after tested positive and symptoms appeared.

According to Merck, clinical trials shown that for patients with mild to moderately symptomatic corona but at risk of aggravation, the drug had an effect of reducing the risk of hospitalization and death by about 50%. The company planned to produce 10 million treatment dosage by the end of 2021, and would invest in its own plants in eight countries around the world by the end of 2022 to increase the annual production to 20 million.

Japan's Ministry of Health, Labor and Welfare was proceeding with procurement discussions with Merck so that Molnupiravir could be used domestically with special approval by the end of the year. This Ministry envisioned that if a license was granted overseas, such as in the United States, and if it applied for approval in Japan, it would get special approval with simplifies examinations.

Prime Minister Fumio Kishida said at a press conference on the 1^st that "We will secure the required amount of approved drugs with the aim of putting them into practical use by the end of the year, which is the trump card for early treatment."

In the UK, about 40,000 new infections occurred daily, but the number of deaths and serious illnesses had not increased rapidly, so the path of coexistence with Corona had not changed. However, the number of inpatients was increasing slightly at the moment, and there was a concern that the medical system might be tight in winter. Javid the Health Secretary said on Wednesday that "It's a historic day for Britain. We are planning to administer Molnupiravir to patients as soon as possible”.

Molnupiravir, a compound drug, was easier to manufacture than vaccines and antibody cocktails. In October, Merck announced that it would license Molnupiravir to a non-profit organization (NPO) "Pharmaceutical Patent Pool (MPP)" that was created by UN affiliates. Generic drug manufacturers could be able to produce it cheaply for developing countries. It would be an important option in areas where vaccine supply had been delayed, such as in African countries.

              So, the UK has approved a drug developed by Merck for the new coronavirus. This will be the world's first approval of a new corona antiviral drug that can be taken at home. It is nice to know that Merck will license Molnupiravir to a non-profit organization (NPO) "Pharmaceutical Patent Pool (MPP)" created by UN affiliates. Generic drug manufacturers will be able to produce this drug cheaply for developing countries soon.