Merck KGaA (MRCG.DE) announced on Wednesday that the U.S. Food and Drug Administration (FDA) had halted the initiation of new patients on its multiple sclerosis drug evobrutinib, resulting in a decline in the share price of the German pharmaceutical company.
As per Reuters, Merck has been in the lead in the quest to develop Bruton’s tyrosine kinase (BTK) inhibitors for the treatment of multiple sclerosis. Analysts have been deeply concerned about the class’s acceptability, however.
Merck shares were 6.3% lower at 10:37 GMT, putting them at the bottom of Germany’s blue-chip DAX index. Merck stated that the FDA’s decision was in response to phase III laboratory results that suggested drug-induced liver injury. The two identified cases were asymptomatic, and the patients’ liver enzymes returned to normal after discontinuing the study drug.
“Merck is working closely with the FDA to determine the optimal next steps for the benefit of patients in ongoing and future evobrutinib trials,” the company said in a statement.
The company must now suspend the enrollment of new evobrutinib patients and studies involving patients who have taken the medication for less than 70 days.
The decision of the FDA affects only two patients. 2,000 participants have already been enrolled in phase III clinical trial, and the ongoing study will continue as intended. Merck anticipates presenting the initial findings from this investigation during the fourth quarter of 2023.
In June 2022, the FDA placed a partial pause on a trial evaluating Sanofi’s (SASY.PA) rival candidate, tolebrutinib, resulting from its $3.7 billion acquisition of Principia Biopharma in 2020. The trial was halted due to concerns regarding harmful effects on the liver. This meant that the recruitment of new participants ceased.
In the development, contest is rem ibrutinib from Novartis (NOVN.S) and fenebrutinib from Roche (ROG.S).
