After Regeneron’s high-dose Eylea received a surprising FDA snub, the FDA disclosed cleaning and procedural issues at Catalent, the manufacturer linked with the rejection.
Regeneron attributed the rebuff to problems at an unnamed third-party filler, which was originally confirmed as Catalent by Bloomberg. The results of the FDA's May inspection at Catalent's facility in Bloomington, Indiana, include three observations: missed sanitization procedures, equipment issues and inadequate maintenance.
“Catalent’s Bloomington facility recently underwent a scheduled pre-approval inspection for aflibercept 8 mg., during which the regulator made three observations,” a spokesperson told Fierce Pharma over email. “Catalent takes all regulatory observations seriously and has already provided proposed corrective and preventative actions to address these observations. We will continue to support the agency’s ongoing review of our response as we work to bring this review to a satisfactory close.”
For one, the FDA flagged a manufacturing suite that featured a weighing device in a “deteriorated state,” tape peeling from a wall surface, ceiling filter discoloration and a cart with a rusty wheel. The agency also noted a dented filter and a receiving dock leading outside with an inadequate door frame seal.
Cleaning was skipped on some filling line aspects and a maximum clean hold time limit, where cleaning would be repeated before machine assembly, wasn’t established on the flexible fill line, according to the FDA’s inspectors. A “lack of good aseptic technique” was also observed in one instance, along with unsanitized gloved hands.
The manufacturer is no stranger to FDA dings. Last year, its Belgium operations received not one but two Form 483’s within a year for issues spanning equipment problems and unverified backup data. One of the warnings contributed to supply strains that affected Novo Nordisk's Wegovy launch.
The company also laid off hundreds of workers last year in Maryland, Texas and Indiana in an effort to cut costs. After warnings of reduced sales and productivity issues at three of its plants, its delayed third-quarter revenues came in at $1.04 billion, a 19% year-over-year decline.
Meanwhile, Regeneron remains committed to bringing the higher-dose version of its Eylea to the market by working closely with the FDA and Catalent, it noted in a statement at the time of the snub. The rejection was solely due to the filler issues as the FDA didn’t request additional data or note any problems with the med’s efficacy and safety or labeling.
The drug previously showed off exceptional efficacy results, giving the company hope in a looming market battle with Roche’s Vabysmo. High-dose Eylea is “the first to demonstrate that patients with diabetic macular edema can immediately be treated with every 12- or 16-week dosing after their initial monthly doses and experience lasting vision control,” said Regeneron President and Chief Scientific Officer George Yancopoulos, M.D., Ph.D, in the drug’s two-year data readout.