FDA places partial clinical hold on initiation of new patients in evobrutinib study

Key takeaways:

• FDA paused initiation of new patients on evobrutinib, an oral inhibitor of Bruton’s tyrosine kinase for relapsing-remitting MS.
• Laboratory values of two patients were suggestive of drug-induced liver injury.

Merck KGaA announced the FDA has paused the initiation of new patients on evobrutinib for relapsing-remitting MS, as well as those with less than 70 days exposure to the treatment in the United States.

According to a release from Merck, the ongoing, fully enrolled phase 3 Evolution clinical trial of evobrutinib — an oral, CNS-penetrating inhibitor of Bruton’s tyrosine kinase — will continue as planned with all participants remaining on treatment, as they have surpassed the 70-day exposure threshold.

The FDA based its decision on two recent reports of laboratory results indicative of drug-induced liver injury. Per the release, both patients were asymptomatic, did not require medical intervention or hospitalization and their liver values returned to normal after discontinuing the study medication.

The clinical trial has been closely monitored by an independent data monitoring committee, including hepatologists, since it began. Results of the trial are expected in the last quarter of 2023.

Merck KGaA will work with external experts and the committee to examine whether predisposing factors may have led to the liver injuries and will consult with the FDA regarding current and future trials of evobrutinib.