Japan asks doctors to hold new Tavneos prescriptions; approval revocation under review
In short
Japan's health ministry told medical bodies on 21 October to refrain from giving the vasculitis drug Tavneos (タブネオス, avacopan) to new patients. It is considering administrative action, including revoking approval, by the end of the year. The ministry says 23 patients have died of liver dysfunction after taking the drug, and in 6 of those cases a link to the drug cannot be ruled out.
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Japan's health ministry on 21 October asked medical institutions to refrain from giving the vasculitis drug Tavneos (タブネオス, generic name avacopan) to new patients. It notified the Japan Medical Association and related academic societies and reported the step to an expert subcommittee the same day. Patients already taking the drug are asked to stop or to consider switching to alternative treatment. The ministry plans to decide on administrative action, which may include revoking the drug's approval, by around the end of the year. [ 1 , 2 , 4 , 5 , 7 ]
The ministry says 23 patients have died of liver dysfunction after taking the drug, and that a causal link to the drug cannot be ruled out in 6 of them. Jiji reported that Kissei Pharmaceutical announced 20 deaths in May, that one was later found to have a different cause, and that 4 new deaths were confirmed, bringing the total to 23. Nippon TV said about 12,000 people are thought to have used the drug in Japan since sales began in 2022. [ 1 , 3 , 5 , 7 ]
The ministry said the reliability of the materials submitted when approval was sought may be in question, according to Jiji. Mainichi reported that the Pharmaceuticals and Medical Devices Agency (PMDA) confirmed in October improper handling in the trial and that it was not explained during the approval review. It reported the agency told the ministry it was difficult to judge that the drug's efficacy had been verified. Nikkei said the initial analysis did not show superiority over the comparator drug, and an outside expert committee then re-judged 9 cases. The people who selected the candidate cases knew which drug each patient had received, which the ministry treated as a problem. [ 1 , 3 , 4 ]
Nikkei reported that the ministry judged the trial results unsuitable as evidence of efficacy, and that the benefit therefore does not outweigh the risk. Patients who continue until they switch are asked to have regular liver function tests. [ 4 ]
Overseas, Europe revoked approval in August, and revocation has been recommended in the United States. Nikkei said the recommendation came in April and a hearing for the company is under way. It added that the UK in September halted new administration and set out an intention to revoke approval in March 2027 after a six-month transition for current patients. Mainichi added that a paper reporting the drug's efficacy was retracted, and that a safety bulletin warning of serious liver damage was issued in Japan in May. [ 1 , 2 , 3 , 4 ]
Why it matters
Patients now taking the drug are being asked to stop or consider other treatment, and the ministry may revoke the approval within the year. The outlets report that Europe has already revoked its approval and that US regulators have recommended revocation.
Key facts
- On 21 October the health ministry notified the Japan Medical Association and related bodies to refrain from giving Tavneos (avacopan) to new patients, and reported this to an expert subcommittee the same day. [ 1 , 2 , 4 , 7 ]
- Patients already taking the drug are asked to stop or to consider switching to alternative treatment. [ 1 , 2 , 4 , 5 ]
- The ministry plans to decide on administrative action, including possible revocation of approval, by around the end of the year. [ 1 , 2 , 3 , 4 , 5 , 9 ]
- The ministry says 23 deaths from liver dysfunction have been reported; a causal link to the drug cannot be ruled out in 6 of them. [ 1 , 3 , 5 , 7 ]
- Europe revoked approval in August, and a revocation has been recommended in the United States. [ 1 , 2 , 3 , 4 ]
- The drug was developed by a US company and is sold in Japan by Kissei Pharmaceutical (キッセイ薬品工業). [ 1 , 2 , 3 , 7 ]
- Around 12,000 people are thought to have used the drug in Japan since sales began in 2022. [ 5 ]
Confirmed by several sources
- The health ministry asked for new administration of Tavneos to be withheld and for patients on the drug to stop or consider switching treatment. [ 1 , 2 , 3 , 4 , 5 , 7 , 9 ]
- The ministry is to consider administrative action, including revocation of approval, by around the end of the year. [ 1 , 2 , 3 , 4 , 5 , 9 ]
- 23 deaths from liver dysfunction have been reported, with a causal link not ruled out in 6. [ 1 , 3 , 5 , 7 ]
- European approval was revoked in August, and revocation has been recommended in the United States. [ 1 , 2 , 3 , 4 ]
Still unclear
- How many of the 23 deaths were caused by the drug. The ministry says a causal link cannot be ruled out in 6 cases; the documents do not say what the link is in the others.
- Whether the approval will be revoked. The ministry says it will decide on administrative action, which may include revocation, by about the end of the year; no decision has been announced.
- The number of deaths reported. TBS describes 'more than 20' deaths and Livedoor repeats the 20 deaths Kissei announced in May, while the ministry figure given by other outlets is 23. Jiji says one of the original 20 was later found to have a different cause and 4 new deaths were confirmed.
What local media are saying
Timeline, local time
- Mainichi and TBS publish reports that the health ministry has decided to ask for new administration of Tavneos to be withheld, following a subcommittee meeting held on 21 October. [ 1 , 2 ]
- Jiji reports the ministry's policy, saying the reliability of the materials submitted for approval may be in question. [ 3 ]
- Nikkei reports that the ministry has notified prefectures, medical and pharmacist associations and academic societies. [ 4 ]
- TBS runs a follow-up on 22 October saying the ministry decided the day before to make the request. [ 8 ]