Sanofi's Late-stage Studies Of Tolebrutinib In Multiple Sclerosis And Myasthenia Gravis Put On Hold

Sanofi (SNY) on Thursday said that the U.S. Food and Drug Administration (FDA) has put partial clinical hold on Phase 3 studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis due to some cases of drug-induced liver injury found in patients enrolled in these studies .

Consequently, new enrollment in these studies is paused and participants who have been in the study for less than 60 days will suspend study drug. However, participants who have completed at least 60 days in the study can continue the treatment, the company said in a statement.

The company said "majority of the impacted patients were determined to have concurrent complications known historically to predispose to drug-induced liver injury."

Following talks with the FDA about these cases, study protocols and enrollment criteria were revised in May 2022.

Enrollment in these trials continues with the revised study protocols and enhanced safety monitoring in countries outside of the U.S, Sanofi said.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Longmont Colorado -based Royal Crest Dairy is recalling 2% Chocolate Milk citing the potential to be contaminated with undeclared egg, a known allergen, the U.S. Food and Drug Administration said. The recall involves Farmer's 2% Reduced Fat Chocolate Milk Pints with the code date of AUG-22. ANI Pharmaceuticals, Inc. (ANIP) Monday announced a wider loss for the second quarter, despite a 52 percent surge in revenues. For the full year 2022, the company reiterated the adjusted earnings per share range, revenue guidance and raised Cortrophin revenue outlook. The company reported a quarterly... Shares of BioNTech SE were losing around 4 percent in the morning trading in Germany and around 5 percent in the pre-market activity on Nasdaq after the German Covid-19 vaccine maker reported sharp drop in profit and revenues for the second quarter. However, the company recorded strong growth in first-half results. Further, the company maintained BioNTech COVID-19 vaccine revenue guidance
Follow RTT