AveXis, a gene therapy company acquired by Novartis in 2018, is to expand its manufacturing capacity with the purchase of an advanced biologics facility in Colorado, US. This coincides with the US regulatory review of the company’s gene therapy for spinal muscular atrophy (SMA), a neuromuscular disease.
The Food and Drug Administration is expected to deliver a decision on marketing authorisation in May. AveXis will also seek regulatory approvals for the therapy in the EU and Japan.