FDA Concerns At Catalent Site Spurred Novo Nordisk's Wegovy Supply Woes: Report

Last week, Catalent Inc CTLT received an FDA write-up for its syringe filling facility in Belgium, "allegedly" the culprit behind supply shortage for Novo Nordisk A/S's NVO obesity drug Wegovy, reported BioProcess International reported.

• An FDA inspection of the CDMO's filling site in Brussels yielded a Form 483, the publication said, calling it a "recent" inspection.
• "We are treating the FDA's 483 observations at the Brussels, Belgium, site very seriously and are working closely with them to resolve these, and with customers to minimize any potential disruptions this may cause to their supply chains," a Catalent spokesperson told BioProcess Insider.
• Related: Novo Nordisk Shares Slump As Wegovy Hits US Supply Issues; Deutsche Bank Downgrades.
• While the publication reports that Catalent could not confirm Novo Nordisk is a customer at the Brussels site, the BioProcess report referenced a note from Jefferies analyst David Windley naming the Brussels site as the primary fill-finish supplier for Novo's Wegovy. 
• In the note, Windley blamed the 483 for Wegovy's recent supply hurdles. He also noted that the site had been handed 12 483s in nine FDA visits.
• Catalent says its Brussels facility stands at 265,287 square feet on its website. It boasts one of the largest syringe-filling capacities in Europe at over 175 million units per year, the CDMO says.
• Novo Nordisk's shortage news came just a few days after it announced an investment of DKK 17 billion to expand its manufacturing hub in Kalundborg, Denmark, with three new facilities.