Japanese drug firm Shionogi to apply for Covid-19 pill approval after trials show ‘reduces virus multiplying in body’
- ‘Extremely good’ trial results show pill effective in reducing coronavirus; if approved will be first such pill developed by a Japanese drug maker
- Drug, developed for mild-to-moderate cases, is effective against Omicron; aim is to supply Japan with around half a million doses by end of month
Japanese pharmaceutical firm Shionogi & Co. said Monday it is looking to apply for approval of its oral Covid-19 drug as early as next week after mid-phase clinical trials showed it was effective in reducing the coronavirus in the body.
The results of “Phase 2a” clinical trials of the drug known as S-217622 are “extremely good,” Shionogi President Isao Teshirogi said during a press conference. If approved, it would be the first such pill developed by a Japanese drug maker.
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The drug was developed for mild-to-moderate coronavirus cases, regardless of whether patients are at risk of hospitalisation. It is believed to prevent the virus from multiplying in the body.
In an analysis of 47 patients with mild-to-moderate Covid-19 symptoms, Shionogi found that subjects who took the drug orally once a day for five days showed rapid reductions in viral load and a tendency toward improvement in symptoms compared with those who were given a placebo.
There were no cases of symptoms worsening in the group that received the drug, while two in the group which took the placebo developed severe symptoms.
The conditional early approval system allows drug makers to skip the final stage of clinical trials once a certain level of efficacy and safety has been confirmed, according to the Ministry of Health, Labour and Welfare.
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The system applies in cases where effective treatments for a disease are scarce, and clinical trials may be protracted due to few subjects.
In May 2020 the health ministry gave special approval to remdesivir, an antiviral drug developed by US firm Gilead Sciences Inc., three days after the company filed the application.
The oral Covid-19 drug molnupiravir was granted special approval in December 2021, around 20 days after US pharmaceutical firm Merck & Co. filed the application.
