Tolebrutinib

[TonyiaR7]

I am looking forward to know about Tolebrutinib the new therapy for non-relapsing SPMS . The long list of DMTs are not viable candidates for my delicate body. I hope I am a candidate for this therapy to slow down my progression. In trials, some claim it made them feel better

[hopeandgrace]

never heard of it thanks for sharing

[kycmary]

Hi Tonyia I pray it helps you too, I have never heard of this DMT but I do hope it helps. Mary

[bxrmom]

I found this article that came out today: nationalmssociety.org/news-...

I hope that it will be something that you will be able to take. Keep us updated when you know more!

[felafelbowl in reply to bxrmom]

i hope it gets approved as i could use it. but it sounds like it will be awhile.

[Greentime]

A drug for SPMS is good news. Thank you for sharing and I hope it helps you!

[grammyshay]

I am looking forward to hearing about it!

[YAYA2three]

I've never heard of it until your comment.Please share what you find

[BettysMom]

The application seeking approval of tolebrutinib for treatment of MS is currently under priority review. The final decision is expected by 28 Sept 2025.

The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor tolebrutinib to treat multiple sclerosis (MS).

As its name suggests, priority review means that the FDA will speed its regulatory evaluation of the oral therapy, completing it in six months instead of the usual 10. A final decision is now expected by Sept. 28, according to a company press release.

Sanofi is specifically asking the agency to approve tolebrutinib for two indications: to treat nonrelapsing secondary progressive MS, known as SPMS, and to slow disability progression independent of relapse activity, or PIRA, in adults with MS.

“If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat nonrelapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity,” the release stated.

Tolebrutinib is also being considered for approval in Europe, per the release.

[Tazmanian]

The best suggestion I have is to talk to your neurologist good luck

[lbenmaor]

Tonyia,

I hope it helps you. Leslie