(News Bulletin 247) – Merck announced on Wednesday that US health authorities had asked it to suspend the recruitment of a clinical study after the appearance of liver damage in some patients.
The Food and Drug Administration (FDA) requirement is for a Phase III trial of evobrutinib, an investigational antibody, in the treatment of relapsing-remitting multiple sclerosis.
The German pharmaceutical group says it is working closely with the FDA to determine the best way forward to continue the study.
He said the FDA’s decision is based on the evaluation of two recently reported cases of drug-induced liver injury that were identified during the study.
In its statement, Merck points out that the two patients are asymptomatic, did not require medical intervention or hospitalization and that their liver enzyme levels have normalized following the discontinuation. of the treatment.
The first results of the phase III clinical trial on evobrutinib are still expected during the fourth quarter.
Listed on the Frankfurt Stock Exchange, Merck shares fell 5.1% on Wednesday morning following this announcement, signing by far the largest drop in the DAX index.
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