BERLIN (Reuters) – Germany’s Merck KGaA said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its evobrutinib drug, sending its share price plunging by as much as 6.3% in the early hours of trading.
The FDA’s decision was in response to laboratory values suggestive of drug-induced liver injury during phase III studies, Merck said, stressing that the two cases identified had been asymptomatic and the patients’ liver enzymes had fully normalized after discontinuation of the study medication.
“Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib,” the company said in a statement.
The regulator placed a partial clinical hold on the initiation of new patients on evobrutinib as well as patients with less than 70 days exposure to study medication in the U.S., according to the statement.
Evobrutinib is a so-called BTK inhibitor designed to block white blood cells from launching an immune response at healthy cells. It is seen as a potential treatment for relapsing multiple sclerosis.
(Writing by Rachel More, Editing by Friederike Heine)
