Tolebrutinib – Talk Bio

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 month ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

4 months ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

4 months ago talkbio0Tagged Breakthrough Therapy, Bruton 's tyrosine kinase inhibitor, Deferred, GEMINI trial, HERCULES trial, Multiple Sclerosis, NDA, nrSPMS, PERSEUS trial, regulatory review, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review

Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis

1 year ago talkbio0Tagged BTK Inhibitor, Clinical Research, GEMINI 1, HERCULES, Multiple Sclerosis, non-relapsing, nrSPMS, regulatory, regulatory approval, sanofi, Tolebrutinib

Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval