The $3.7 billion centerpiece of Paul Hudson’s R&D strategy for Sanofi has hit a setback. Seeing cases of drug-induced liver injury, the FDA has slapped a partial clinical hold on phase 3 trials of the candidate, raising still more doubts about the merits of Sanofi’s Principia Biopharma takeover.
Sanofi struck a deal to buy Principia in 2020, with Hudson brushing off concerns about the limitations of midphase data on tolebrutinib and broader doubts about the efficacy of BTK inhibitors in autoimmune diseases to make the asset a key part of his attempt to kick-start the R&D engine after taking over as CEO. Now, the FDA has tapped the brakes on Sanofi’s push to get the molecule to market.
The action affects phase 3 clinical trials of the Bruton’s tyrosine kinase inhibitor in multiple sclerosis and myasthenia gravis. Under the terms of the partial FDA clinical hold, enrollment at U.S. sites is stopped and dosing is suspended in existing subjects who have been in the study for fewer than 60 days. Sanofi can keep dosing participants who have completed at least 60 days in the study.
Officials at the FDA imposed the restrictions in response to “a limited number of cases of drug-induced liver injury,” Sanofi said. According to the company, most patients had “concurrent complications known historically to predispose to drug-induced liver injury,” and the elevated laboratory values were reversible after they stopped taking the treatment.
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