Merck KGaA’s Phase III Bruton's tyrosine kinase (BTK) inhibitor asset evobrutinib for multiple sclerosis (MS) has been put on partial clinical hold by the US Food and Drug Administration after liver events, increasing concerns over a possible class safety effect.
Clinical Hold For Merck KGaA’s BTK Inhibitor Evobrutinib For MS Raises Class Safety Fears
Third To Be Hit With MS Clinical Hold
Adding to a growing pattern within the BTK inhibitor pipeline for multiple sclerosis, the US FDA has placed Merck’s evobrutinib on a partial clinical hold following two liver injury incidents, prompting questions over its ultimate approvability.
More from Clinical Trials
• By
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
• By
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
• By
With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.
• By
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
More from R&D
• By
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.