Ann: FDA Provides Clear Feedback for ODD Approval, page-264

Hi All,
Amylyx have announced revenue for the Dec Qtr. 108.42 million, bear in mind it was only approved in Sept 2023 and as outlined at the SGM RELYVRIO faces a few challengers. [There appears to only be around 3600 patients on it so far.]

Greater efficacy and less side effects would see a far greater take up, if MPL achieves these milestones.

Of those who started riluzole, 54 (15.4%) subsequently discontinued treatment. The most common reasons for discontinuation were gastrointestinal adverse effects (24.8%), including nausea, abdominal discomfort, constipation, and anorexia. Other adverse effects (including fatigue/malaise) accounted for 13.0%, deranged liver function 11.1%, and allergic reactions 9.3%. 13% discontinued due to ongoing ALS progression. In the remainder, the reason was unclear. Median time until discontinuation was 3 months for adverse effects and ALS progression (IQR 1.8–3.3 and 2.0–5.0, respectively) and 4.5 months for deranged liver function tests (IQR 2.5–6.0).