Amylyx Submits NDA to the US FDA for AMX0035 to Treat Amyotrophic Lateral Sclerosis

November 3, 2021 Auto Bot ALS, Amylyx, FDA, NDA, regulatory 0

Shots:

  • The NDA is based on CENTAUR trial evaluates AMX0035 vs PBO in 137 patients with ALS
  • The results showed that patients receiving AMX0035 had a significant functional decline at the end of the 6mos. as measured by the ALSFRS-R. In an interim survival analysis @3yrs., 44% lower risk of death, median survival duration (25.0mos. & 18.5mos.), AEs and discontinuations were similar b/w AMX0035 and PBO groups 24wks.
  • The company plans to submit an MAA for AMX0035 to the EMA’s CHMP at the end of 2021 and plans to start a P-III clinical trial in the EU & US in Q4’21. The therapy is being evaluated in the P-III PHOENIX trial for ALS, based on the results from the CENTAUR trial

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Businesswire

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