Novartis Manufacturing Facility Approved for Zolgensma Production

Novartis said the FDA has given the go-ahead for its gene therapy manufacturing facility in Durham, N.C., to manufacture the spinal muscular atrophy drug Zolgensma (onasemnogene abeparvovec) and other gene therapies.

Novartis already has a gene therapy manufacturing facility in Libertyville, Ill., but said it will use the Research Triangle Park plant for collaborations with the government and the life sciences community.

The company currently has at least 20 adeno-associated virus gene therapies in its pipeline. In addition to Zolgensma production, the Novartis said it will use the 170,000-square-foot facility to create gene therapy products for use in current and future clinical trials.