UPDATED: Novartis manufacturing facility in North Carolina gets FDA all-clear to produce, ship gene therapies
Just one day after Vas Narasimhan announced $1 billion in cuts amid a company-wide restructuring, the American-Swiss pharma received FDA clearance to produce its spinal muscular atrophy drug Zolgensma out of its North Carolina manufacturing facility.
The pharma made the announcement earlier Tuesday, which allows the massive, 170,000-square-foot facility to make the drug — along with testing and shipping it. The commercial licensure is not just limited to Zolgensma, according to Novartis — the plant will also have the ability to produce certain gene therapy products for use in clinical trials.
“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.
The facility, located in the heart of the Research Triangle Park in Durham, North Carolina, will be the second site to produce Zolgensma — with the first one in Libertyville, IL, approved in 2019. The North Carolina facility would have been Novartis’ third manufacturing plant for Zolgensma, but the pharma walked away from its planned Longmont, CO, plant last year in the face of declining sales.
This is the latest development surrounding the gene therapy designed for SMA, and which was at the center of scandal more than two years ago after safety concerns were brought up and Novartis’s gene therapy division AveXis informed the FDA about a data manipulation issue that didn’t end up affecting its approval. Several AveXis employees, including two of its top scientists, were fired in the aftermath.
Novartis currently has more than 20 gene therapies in its AAV-based pipeline, and while it was advancing therapies for Rett syndrome and Friedreich’s ataxia, for example — those programs have been dumped, the company said at an R&D event in December.
Editor’s note: This article has been updated to note that Novartis now has more than 20 gene therapies in its AAV pipeline, and the two programs previously mentioned were dropped four months ago.