The US Food and Drug Administration has hit pause on patient enrollment for German drugmaker Merck’s multiple sclerosis drug candidate evobrutinib after initial lab results indicated liver injury during Phase III studies.
Although the FDA’s decision only affects two patients, the news sent Merck’s Frankfurt-listed shares falling over 6% on Wednesday.
According to reports, two cases identified had been asymptomatic and their liver enzymes had fully normalized after discontinuation of the study medication.
Merck is hoping that evobrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, will help to slow the progression of MS.
In a statement, Merck said it is working closely with the FDA to establish the best path forward for patients in current and future trials.
The pharmaceutical company will now have to hold the initiation of new evobrutinib patients and halt studies involving patients who have been taking the drug for less than 70 days.
Merck expects to present the first data from the study in the fourth quarter of 2023.
Merck's New York-listed shares were down 0.4% at the open Wednesday morning.
Contact Angela at angela@proactiveinvestors.com
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