High-Stakes Meeting Between Avexis and FDA Will Set the Course for Gene Therapy and Dying Kids - (TheStreet via NewsPoints Desk)

  • 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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