Another BTK Inhibitor, Evobrutinib, Faces Partial Clinical Hold by FDA Due to Hepatotoxicity Concerns

On April 12, Merck KGaA announced that the FDA has partially placed evobrutinib on clinical hold for newly enrolled patients and those who have been dosed for less than 70 days. However, the ongoing Phase III EVOLUTION study of evobrutinib for the treatment of relapsing multiple sclerosis (RMS) in the United States will continue as planned since all participants have been dosed for over 70 days, with clinical trial results still expected to be released in the fourth quarter of 2023 as scheduled.

FDA's decision was primarily based on the evaluation results of two recent patient cases. The results showed that drug-induced liver injury was confirmed in two patients during the Phase III study. However, the patients did not exhibit related symptoms and required no medical intervention or hospitalization. Their liver enzyme levels returned to normal after discontinuation of the study drug.

BTK Inhibitors in Non-Oncology Fields: Progress Hindered by Setbacks

In December 2022, orelabrutinib, jointly developed by Biogen and InnoCare Pharma, was also put on hold by the FDA due to drug-induced liver injury. In February 2023, Biogen and InnoCare Pharma officially "parted ways," with Biogen returning the overseas rights of orelabrutinib. InnoCare Pharma stated that the Phase II clinical study of orelabrutinib for the treatment of multiple sclerosis was still ongoing, with interim analysis results expected to be released in the second quarter of 2023.

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