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BackVasculitis drug: ``Problems with application materials'' Request for discontinuation of new administration - 23 deaths from ``Tabneos'' - Ministry of Health, Labor and Welfare
Vasculitis drug: ``Problems with application materials'' Request for discontinuation of new administration - 23 deaths from ``Tabneos'' - Ministry of Health, Labor and Welfare
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時事通信1 hour agoHealth2 min readJapanView original

Vasculitis drug: ``Problems with application materials'' Request for discontinuation of new administration - 23 deaths from ``Tabneos'' - Ministry of Health, Labor and Welfare

Kissei Pharmaceutical Industry ordered to report, considering revocation of approval

Kissei Pharmaceutical IndustrytabneosMinistry of Health, Labor and Welfare

Quick Look

  • The Ministry of Health, Labor and Welfare has requested the suspension of new administration of Tabneos, a vasculitis treatment drug sold by Kissei Pharmaceutical Co., Ltd., after 23 patients died due to liver dysfunction.
  • Administrative sanctions, including revocation of approval, will be considered within the year as there are doubts about the reliability of the approval application materials.

AI-generated summary

Why It Matters

Tabneos will begin domestic sales in June 2022. European and American regulatory authorities pointed out inappropriate research methods in the clinical trial, and approval was revoked in Europe.

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The Ministry of Health, Labor and Welfare announced its response policy on the 21st in response to a series of deaths of patients after receiving the vasculitis treatment drug Tabneos, which is sold domestically by Kissei Pharmaceutical Co., Ltd. (Matsumoto City, Nagano Prefecture). "There may be a problem with the reliability of the materials submitted at the time of application for approval," and once again requested medical institutions to suspend new administration. Administrative sanctions, including the possibility of revocation of approval, will be decided by the end of this year.

Kissei Pharmaceutical ordered to report 20 deaths from vasculitis treatment - Ministry of Health, Labor and Welfare

Tabneos will begin domestic sales in June 2022 after receiving approval from the Ministry of Health, Labor and Welfare. The package insert listed liver dysfunction as a serious side effect.

In May, the company announced that 20 people had died due to liver dysfunction, but it was later revealed that one person had a different cause of death. According to the ministry, four new deaths were confirmed, bringing the total to 23 people who died from liver dysfunction. In six of these cases, a causal relationship to the drug could not be ruled out.

The approval was based on the results of a clinical trial conducted by the U.S. pharmaceutical company that developed the drug. However, regulatory authorities in Europe and the US pointed out inappropriate research methods. Approval was revoked in Europe in August, and revocation was recommended in the United States as well.

What to Watch

AI outlook — possibilities, not facts

  • Administrative disposition (including revocation of approval) will be decided within this year.

    Very likely · Within months

Open Questions

  • Final decision on revocation of approval
  • The full scope of the clinical trial data issue

Related Topics

Kissei Pharmaceutical Industry
OrganizationsMinistry of Health, Labor and Welfare
PlacesMatsumoto City, Nagano Prefecture
TopicstabneosMinistry of Health, Labor and Welfarevasculitisliver dysfunctionpharmaceuticals
This article was originally published by 時事通信.

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