Gilenya and Als

[rms000]

Has anyone heard about the drug Gilenya? Gilenya is approved for MS patients and TDI is considering starting a phase 2 trial on ALS patients to see if it will slow the progression. Has anyone used this drug off label?

 

[trfogey]

Has anyone heard about the drug Gilenya? Gilenya is approved for MS patients and TDI is considering starting a phase 2 trial on ALS patients to see if it will slow the progression. Has anyone used this drug off label?

If you read the forums at the website of the organization that is setting up the Phase 2 trials, you'll find a very long thread on this very subject.

And please note -- encouraging people to use a drug off-label undermines the clinical trial process and makes it more difficult and time-consuming to get drugs approved for ALS. If everybody's going off-label, who fills the trials, especially the important low-dose, high-dose, and placebo branches of the trial.

Finally, there are some very serious side effects and some frightening adverse events reported with Gilenya in MS patients -- the drug that Gilenya was trialed and approved for. By going off-label, you might just be taking your life in your hands.