The FDA has also recommended suspension of clinical trials involving higher doses of TAK-475 because of concerns over elevated levels of the enzyme transaminase - an indicator of possible liver damage. An increased frequency of elevated transaminase - including some severe cases – was observed compared with that in control groups in a pooled analysis of Phase II and III US and European study data. This pattern has not been seen to date with lower doses of TAK-475, however, where frequencies are comparable with those in control groups.
TAK-475 is a squalene synthase inhibitor currently in Phase II trials in Japan and Phase III trials in the US, Europe and Latin America, either alone or in combination with a statin, for the treatment of hypercholesterolaemia.
Takeda said it would “immediately study the future plans for TAK-475 in the US, Europe and Japan, and such plans will be announced once fixed through discussion with the relevant regulatory authorities”
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