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Japan gives emergency approval to Shionogi's oral COVID-19 drug

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Kyodo News

<p>TOKYO (UPDATE) - Japan&#x27;s health ministry on Tuesday granted fast-track approval to Shionogi &amp; Co.&#x27;s COVID-19 tablet Xocova, making it the country&#x27;s first domestically produced oral medicine against the coronavirus.</p><p>The medicine for COVID-19 patients aged 12 or older with mild symptoms also became the first drug authorized under the new emergency approval scheme established in May.</p><p>&quot;As soon as the distribution system is ready, we plan to start delivering the drug so it can be used for treatment from early December,&quot; Health, Labor and Welfare Minister Katsunobu Kato told a press conference after a panel of experts backed the treatment by a majority.</p><p>The decision on the treatment requiring seven Xocova tablets over five days comes as Japan has been experiencing a rebound in its number of daily COVID-19 cases, with prefectural governments across the country reporting a total of 124,004 on Tuesday, up about 18,000 from a week earlier. The number of deaths totaled 178.</p><p>Tokyo reported 12,758 infections, while Hokkaido and the northeastern Japan prefectures of Iwate and Yamagata logged new record highs.</p><p>The Japanese government has eased restrictions on people&#x27;s activities, including removing its cap on daily foreign arrivals and starting a subsidy program for residents to boost domestic tourism.</p><p>The Pharmaceuticals and Medical Devices Agency, which conducted the preliminary review, acknowledged in a report that it had &quot;obtained sufficient information to presume the drug is effective&quot; from final phase clinical trial results submitted by Shionogi.</p><p>A health ministry panel in July had postponed granting an emergency approval for the drug after the Japanese pharmaceutical firm was unable to demonstrate its efficacy in its mid-phase clinical trials.</p><p>Although the trials showed effectiveness in reducing coronavirus in the body, there were no substantial differences in alleviating a total of 12 symptoms such as headaches and nausea between those given the drug versus the placebo.</p><p>But an analysis of five symptoms characteristic of the Omicron strain -- runny nose, sore throat, cough, fever and fatigue -- in the final phase of the trials showed the drug shortened symptoms from eight days to seven days.</p><p>The final phase, conducted in Japan, South Korea and Vietnam, administered the drug once daily for five days to patients with mild or moderate COVID-19 symptoms, irrespective of their risk of developing severe symptoms or vaccination status.</p><p>The Japanese government has agreed to purchase doses sufficient for one million people once the use of the drug, the third oral treatment in the country, is greenlit.</p><p>Japan had already authorized the use of two oral COVID-19 drugs developed by U.S. pharmaceutical firms Pfizer Inc. and Merck &amp; Co., respectively, for patients with mild symptoms.</p><p>&quot;We are proud to reach this landmark step which marks the start of our real contribution to people&#x27;s recovery from (COVID-19),&quot; Shionogi said in a statement.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/overseas/11/15/22/japan-to-accept-intl-cruises-after-2-yr-ban">Japan to accept int&#x27;l cruises after 2-yr ban due to pandemic</a></li>	<li><a href="https://news.abs-cbn.com/overseas/11/10/22/japans-8th-covid-wave-could-surpass-previous-waves-peak">Japan&#x27;s 8th COVID wave could surpass previous wave&#x27;s peak</a></li></ul><div><strong>==Kyodo</strong></div><div><strong>FROM THE ARCHIVE</strong></div><figure class="op-interactive"><iframe allow="autoplay; fullscreen" frameBorder="0" height="100%" id="ivsplayer01" scrolling="no" src="https://player.ivideosmart.com/ivsplayer/v4/dist/html/iframe-src.html?iframeid=ivsplayer01&amp;key=e8c22c015ca9eafa76f1e3edfa03c603&amp;spid=3001339&amp;vid=2244780" width="100%"></iframe></figure><div class="iwantbar">Watch more News on <a href="https://www.iwanttfc.com/#!/browse/Genres/News/tag_id_genres/id_news" target="_blank">iWantTFC</a></div>

A panel of the Japanese health ministry granted fast-track approval to Shionogi & Co.'s oral COVID-19 drug on Tuesday.