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U.S. pauses new patients on Merck MS drug in blow to shares
Merck shares were down five per cent at 0757 GMT on news of the setback, sliding to t bottom of Germany's blue-chip DAX index. The science and technology group must no place on hold the initiation of new evobrutinib patients and halt studies involving pati who have been taking the drug for less than 70 days.
- By Reuters
- Berlin
- Apr 12, 2023
Merck KGaA (MRCG.DE) said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its multiple sclerosis evobrutinib drug, knocking the German drugmaker's share price.
Merck has been ahead in the race to develop a drug from the class known as Bruton's tyrosine kinase (BTK) inhibitors to slow the progression of nerve disease multiple sclerosis. But tolerability of the class has been a big concern for analysts.
Merck shares were 6.3% lower at 1037 GMT and slid to the bottom of Germany's blue-chip DAX index on news of the setback.
The FDA's decision, Merck said, was in response to laboratory results which suggested drug-induced liver injury during phase III studies. 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," it said in a statement.