USFDA pauses initiation of new patients on multiple sclerosis evobrutinib drug: Merck
The company must now place on hold the initiation of new evobrutinib patients and halt studies involving patients who have been taking the drug for less than 70 days.;
United States: Merck KGaA 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.
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