Novartis gets FDA nod to begin making Zolgensma in North Carolina

Novartis can begin producing its spinal muscular atrophy (SMA) gene therapy, Zolgensma, at its North Carolina plant following FDA's approval for a manufacturing license at the site.

The regulatory go-ahead lets Novartis start manufacturing Zolgensma for commercial distribution and also other gene therapies for clinical trials. The 170,000-square-foot plant is located in Research Triangle Park in Durham, North Carolina. It becomes the second Novartis site in the U.S. where the company makes gene therapies, with the first being in Libertyville, Illinois, which began manufacturing Zolgensma in 2019.

“Not only will this facility support the Novartis pipeline through the manufacture of both clinical trial and commercial products, it ultimately allows us to help more patients and families living with rare, genetic diseases,” Christine Fox, president of Novartis Gene Therapies, said in a statement.

Novartis launched its gene therapy in 2019, after a groundbreaking FDA approval. With a list price of $2.125 million, Zolgensma is the most expensive medicine in the world. Novartis has said the drug’s nature as a one-time treatment and strong data support the price, and cost watchdogs on both sides of the Atlantic have agreed. So far, more than 1,800 patients have been treated with Zolgensma globally, the company said.

Novartis competes in the increasingly competitive arena with Roche’s SMA drug Evrysdi.