Novo Nordisk manufacturing facility, and clients, hit by FDA action

Credit: JHVEPhoto / Shutterstock.com

An Indiana pharma manufacturing facility run by Novo Nordisk after its billion-dollar acquisition of Catalent in 2024 has been reprimanded for serious compliance failings.

The US Food and Drug Administration (FDA) classified the site as “official action indicated”, the regulator’s most serious category and one that demands a response of regulatory and/or administrative action from the pharma company.

Novo’s Catalent Indiana fill-finish facility received an FDA Form 483 confirming the inspection classification last week, news that was confirmed by Scholar Rock, one of its clients caught up in the failings.

Scholar’s Biologics License Application (BLA) for its spinal muscular atrophy drug apitegromab was knocked back by the FDA last month due to issues uncovered during a routine general inspection of the Catalent Indiana site in Bloomington.

Scholar was keen to note the issues detailed in the Complete Response Letter (CRL) were “not specific to apitegromab”.

“We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA,” the Cambridge, Massachusetts biopharma company said, adding that it planned to share more information during its third quarter update call in November.

Prior to the company receiving the FDA’s CRL, it had been busy finalising its preparations to launch the drug in the US, plans that had already seen it hire and deploy customer-facing teams.

Another of Novo’s clients for its Catalent Indiana site is Regeneron and its treatment for ‘wet’ age-related macular degeneration, diabetic macular oedema and diabetic retinopathy Eylea.

Regeneron’s application for a supplemental Biologics License Application (sBLA) that would allow Eylea HD (aflibercept) to be used to treat macular oedema following retinal vein occlusion, as well as giving it an expanded four-weekly dosing schedule, has also been delayed.

Novo’s Catalent Indiana facility was the manufacturing filler included in Regeneron’s sBLA and the firm said is planning to submit an application to include an additional manufacturing filler for the product within the next three months.

Novo Nordisk gained the troubled facility when its parent group Novo Holdings struck a $16.5 billion deal to buy the US contract development and manufacturing organisation (CDMO) Catalent at the end of last year. But over the summer an FDA inspection of the plant revealed a litany of failings, from equipment issues to the presence of cat hair, with Stat News subsequently releasing the full FDA report.