Avexis hopes to receive approval next week from the FDA to start a pivotal clinical study of the investigational spinal muscular atrophy drug AVXS-101, TheStreet reported Wednesday.
During the meeting, scheduled for March 1, the drugmaker will also discuss chemistry, manufacturing and controls for AVXS-101 with the agency.
The drugmaker has only treated 15 patients with the therapy to date.
Avexis CEO Sean Nolan expressed confidence that the drugmaker has taken the steps needed to increase manufacturing of AVXS-101.
The news comes after Biogen and Ionis Pharmaceuticals recently received FDA approval of the spinal muscular atrophy drug Spinraza.
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