FDA re­jects pro­fes­sor’s pe­ti­tion seek­ing to pull ‘dan­ger­ous’ Ot­su­ka kid­ney dis­ease drug

The FDA on Mon­day de­nied a pe­ti­tion from an emer­i­tus pro­fes­sor at Ohio State Uni­ver­si­ty who had sought to re­voke the ap­proval of Ot­su­ka’s kid­ney dis­ease drug tolvap­tan, which he said is “dan­ger­ous” and of­fered “neg­li­gi­ble ef­fi­ca­cy.”

Ap­proved by the FDA in 2018 to treat the ge­net­ic dis­ease known as au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease, Ot­su­ka’s tolvap­tan — mar­ket­ed in the US as Jy­nar­que — faced a long and rocky road to mar­ket­ing but quick­ly amassed more than $700 mil­lion in world­wide sales in 2020, up al­most 40% from 2019.

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