Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
The FDA has slapped Novo Nordisk’s Indiana manufacturing plant with its most severe inspection classification, casting a cloud of uncertainty over regulatory timelines for clients of the plant such as Regeneron and Scholar Rock.
The regulator on Monday gave the Novo site, which the company acquired in its $16.5 billion buyout of Catalent in early 2024, its Official Action Indicated (OAI) classification. This designation is given to facilities in an “unacceptable state of compliance” after an FDA inspection, the agency notes on its website. It is not yet clear what specific actions the regulator will require of Novo.
Writing to investors on Monday, analysts at BMO Capital Markets said that while the OAI classification was “expected,” it nevertheless “paints a more difficult path forward for Regeneron and Scholar Rock,” both of which have products that are manufactured at this Indiana site. Violations at this plant have already hobbled both companies: Regeneron in August announced that the FDA pushed back its target decision date for two high-dose Eylea applications, while in September, Scholar Rock was hit with a rejection for its spinal muscular atrophy drug apitegromab.
Novo has previously said that it is working to address problems at the Indiana plant, “but likely not quickly enough for companies with delayed approvals and CRLs [complete response letters],” BMO wrote on Monday. “With no clear timelines on observation resolution, and the recent OAI classification we are less inclined to believe that the issues cited in the observations are under control.”
BMO expects the Indiana plant to continue to be a problem for Regeneron. “We could potentially see another CRL for Eylea HD this October,” the analysts wrote.
Scholar Rock gave a brief statement on the matter on Monday, noting that it is working “closely” with Novo and has asked for a Type A meeting with the FDA to determine the best path forward for apitegromab. Nevertheless, BMO wrote that “persistent CMC [chemistry, manufacturing and control] issues risk further extending timelines for a potential approval.”
An FDA report of its inspection of the Indiana site was made public in August. The document revealed several issues that the facility’s management failed to address. Among these are unresolved instances of contamination, including with cat hair and various bacteria and pests. The facility “failed to determine a root cause of the contamination,” the report read, adding that officials likewise did not “assess the potential impact to the rest of the lot.”
Additionally, the FDA’s inspector noted that the plant had been fielding complaints for years—with some dating as far back as June 2022—over “foreign matter” or “particles” in products that it produced.
