Merck Reports US FDA’s Partial Clinical Hold on New Patient Enrollment of Evobrutinib for Multiple Sclerosis
Shots:
- The US FDA has placed a partial clinical hold on the initiation of evobrutinib (BTK) inhibitor in new patients and those with less than 70 days of exposure
- The decision was based on the response of laboratory results which suggested drug-induced liver injury during the P-III studies (EVOLUTION RMS 1 & 2). The ongoing, fully enrolled P-III program is to continue as planned & the results are expected in the last quarter of 2023
- Evobrutinib, a highly selective, central nervous system-penetrant agent will continue to be closely monitored by IDMC in the P-III program. Merck is working closely with the US FDA regarding current and future trials of evobrutinib
Ref: Merck KgAa | Image: Merck KgAa
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
