Regeneron has received an US Food and Drug Administration (FDA) rejection for a new blood cancer therapy and expects separate regulatory delays for blockbuster ophthalmology drug Eylea HD due to problems at a Novo Nordisk-owned manufacturing site.
The FDA uncovered the issues during an inspection of Catalent鈥檚 filling plant in Bloomington, Indiana. Novo acquired the site as part of its $16.5bn acquisition of the CDMO in December 2024. Regeneron is a customer of Catalent specifically for filling vials of Eylea 鈥� the pharma company鈥檚 lead drug. 聽
In its Q2 results report, Regeneron said that it expects FDA regulatory decisions to be delayed for Eylea HD, the high-dose brand of Eylea in the US. The company is seeking approvals for every-four-week dosing in a pre-filled syringe and for the treatment of macular edema following retinal vein occlusion. Regeneron confirmed the inspection was not specific to Eylea HD, a drug it co-developed with Bayer. There was no date given for the PDUFA dates, which were originally slated for this month.
The delays further weaken Regeneron鈥檚 position in the eye disease market, which has been significantly eroded by Roche鈥檚 rival drug Vabysmo (faricimab). Eylea鈥檚 sales dropped 39% to $754 in the US in Q2, meaning it has now lost blockbuster status in the country, though the revenue drop was also caused by the pickup in sales of its high-dose version.
Regeneron hopes Eylea HD 鈥� whose sales grew 29% this quarter 鈥� will help the company regain market share from Roche. Despite mixed results for its Eylea brand, Regeneron鈥檚 total Q2 sales grew 4% to $3.68bn.
Shortcomings at the Bloomington facility resulted in an FDA complete response letter (CRL) for Regeneron鈥檚 cancer bispecific antibody odronextamab. The pharma company had been seeking a place in the relapsed/refractory follicular lymphoma market for the drug, though the Catalent Indiana site inspection meant the FDA declined to issue approval. The latest CRL means odronextamab has now been rejected a second time by the FDA, the previous decision made due to clinical data concerns in March 2024.
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By GlobalDataNovo has discussed the findings with the FDA and is expected to submit its response next week, while Regeneron confirmed it has made alternate arrangements with third-party fillers. Though new timelines were not given for odronextamab鈥檚 new filing or Eylea HD鈥檚 updated PDUFA dates, Regeneron predicts a fast resolution.
In a conference call on 1 August, Regeneron CEO Len Schleifer played down the severity of observations made during the FDA inspection.
Schleifer commented that the FDA did not request structural changes, adding that the 鈥減rocedural鈥� issues will not last long.
Regeneron鈥檚 problems with Catalent鈥檚 filling site are not unexpected. Before Novo arrived as owners, issues at the plant caused a two month-delay for Eylea HD鈥檚 FDA approval decision in 2023. In November 2024, the FDA also found quality control lapses at the facility, including discovery of a “pest” on the manufacturing line.
The Indiana plant, which has a total area of 950,000 square feet, has received sizeable investments over the past few years for expansion.聽 The site is the main supplier of fill-finish work for Novo Nordisk鈥檚 billion-dollar weight loss drug Wegovy (semaglutide).
Schleifer added in the conference call that the facility was involved in the production of 70 billion doses last year, conducting business 鈥渨ith the vast majority of the top bio-pharmaceutical companies in the world.鈥� As a result, Schleifer added that Regeneron may not be the only company affected by the inspection.
鈥淚 believe that we may not be the only PDUFA that鈥檚 in snare because they do work for virtually all the biopharmaceutical companies,鈥� he commented.
