🚫Amylyx Pharmaceuticals' RELYVRIO Drug Approval Withdrawn by FDA
Amylyx Pharmaceuticals, Inc.; Withdrawal of Approval of New Drug Application for RELYVRIO (Sodium Phenylbutyrate and Taurursodiol) for Suspension, 3 Gram/Packet and 1 Gram/Packet
Summary
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for RELYVRIO (sodium phenylbutyrate and taurursodiol) for suspension, 3 gram (g)/ packet and 1 g/packet, held by Amylyx Pharmaceuticals, Inc. (Amylyx), 43 Thorndike St., Cambridge, MA 02141. Amylyx has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's withdrawal of approval for RELYVRIO due to poor clinical trial results directly impacts Amylyx Pharmaceuticals and its business operations, potentially affecting revenue and market positioning in the ALS treatment sector. Non-compliance with regulatory changes also poses risks for businesses involved with this drug.