Safety setback for BTK blockers as FDA holds fenebrutinib trial

5 December 2023

Roche (ROG: SIX) subsidiary Genentech has provided an update on its multiple sclerosis program, revealing a partial trial stoppage for the oral BTK inhibitor fenebrutinib.

The US Food and Drug Administration has stopped enrollment in the Phase III FENhance I trial, after two recent cases of elevated liver enzymes were discovered.

Genentech said the data were “suggestive of drug-induced liver injury,” a worry that has affected rival BTK blockers under development by Sanofi (Euronext: SAN) and Merck KGaA (MRK: DE).

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