Roche's BTK in­hibitor put on par­tial hold over con­cerns about po­ten­tial liv­er in­jury

Roche’s fene­bru­ti­nib pro­gram in mul­ti­ple scle­ro­sis has been put on par­tial clin­i­cal hold over po­ten­tial cas­es of drug-in­duced liv­er in­jury, the com­pa­ny said Thurs­day.

The BTK in­hibitor class has been trou­bled by liv­er in­jury cas­es, with Mer­ck KGaA’s evo­bru­ti­nib in re­laps­ing mul­ti­ple scle­ro­sis (RMS) and Sanofi’s tole­bru­ti­nib in mul­ti­ple scle­ro­sis and myas­the­nia gravis re­ceiv­ing par­tial holds in June 2022 and April 2023, re­spec­tive­ly. While sev­er­al BTK in­hibitors are cur­rent­ly on the mar­ket to treat blood can­cers, re­searchers be­lieve block­ing the en­zyme can al­so help treat chron­ic in­flam­ma­to­ry and au­toim­mune dis­eases.

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