Japan approves Roche’s therapy for mild to moderate COVID-19 symptoms

SWITZERLAND – Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Roche’s Ronapreve (casirivimab and imdevimab), for the treatment of non-hospitalized patients with mild to moderate COVID-19 via intravenous infusion.

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act.

This approval was an onset of results from the global phase III study in high-risk non-hospitalized patients with COVID-19.

Outside Japan, the antibody combination has been authorized for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada.

Japan, unlike some other countries, did not enforce strict lockdowns or completely close off its borders as soon as the pandemic hit last year.

In April 2020, the government introduced a state of emergency, although the stay-at-home guidelines were voluntary. Non-essential businesses were asked to close, but did not face penalties for not complying.

Restrictions on entry were introduced from some countries, and others were added later on, with entry now barred from 159 countries.

Although it has a large elderly population and densely-populated urban centres, Japan proved relatively successful in controlling the virus initially, and avoiding high death rates.

According to MHLW, new infections have been edging up again across Japan since late June, after an earlier surge in cases peaking in mid-May.

Reported daily cases on Tuesday soared to 3743, which was 1425 more than the previous weekly cases. However, the daily numbers are not at the level they were in May, when at several points, more than 7,000 cases a day were recorded.

As of 19 July, just over 34% of the country’s population had been vaccinated with at least one dose and 22% were fully vaccinated.

Japan is set to host the Olympics and experts have said the daily infection rate needs to fall below 100 in order to hold the Games safely.

A state of emergency is in force in Tokyo, and Olympic events there and in Fukushima prefecture will take place without spectators.

With the directive barring spectators from attending the Olympic event, stadiums and arenas that cost over US$7 billion to build or renovate for the Games will be mostly empty.

This is set to cost the state’s economy a whopping 46.8 billion yen (US$1.3 billion), according to an estimate by Takahide Kiuchi, an economist at the Nomura Research Institute.

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