Biogen/ Ionis ALS therapy set for March FDA AdCom meeting
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The FDA announced that a panel of experts is scheduled to meet on Mar. 22 to discuss the marketing application for tofersen, a treatment for neurodegenerative disorder amyotrophic lateral sclerosis (ALS) developed by Biogen (NASDAQ:BIIB) and Ionis Pharma (NASDAQ:IONS).

The meeting of the FDAâs Peripheral and Central Nervous System Drugs Advisory Committee will be held virtually ahead of the agencyâs Apr. 25 action date for the tofersen new drug application (NDA).
The panelists will consider the approvability of the NDA for ALS linked to a mutation in the superoxide dismutase 1 (SOD1) gene.
The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
In October, Biogen (BIIB) announced that the FDA extended the review period for the NDA by three months as the regulator considered the new information the company submitted for its approval as a major amendment that required additional time for review.

âIf tofersen is approved it will be a feather in Ionis' cap and boost to its credibility,â Seeking Alpha contributor Out of Ignorance wrote despite a Hold rating on IONS stock early this month.