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UPDATED: Regeneron Wins Same-Day Veopoz, High-Dose Eylea US FDA Approvals

Products Produced At Same Catalent Site

 
• By Mandy Jackson

Veopoz (pozelimab) approval showed the FDA was reassured that Regeneron’s contract manufacturer is ready to supply high-dose Eylea, a key product for the company as competition picks up.

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Veopoz approval helped clear the way for Eylea HD decision • Source: Shutterstock

Within hours of US Food and Drug Administration approval of Veopoz (pozelimab-bbfg) for an ultra-rare hereditary disease, Regeneron Pharmaceuticals, Inc. delivered on its recent promise that the delayed FDA approval of high-dose Eylea (aflibercept) would come sooner rather than later. Veopoz and aflibercept 8mg, which are filled and finished at the same Catalent, Inc. site, both were approved on 18 August, since the FDA’s inspections under the pozelimab biologics license application (BLA) apparently cleared up the agency’s lingering questions about the contract manufacturer.

Veopoz was cleared to treat adult and pediatric patients 1 year of age and older with complement hyperactivation, angiopathic thrombosis and protein-losing enteropathy (CHAPLE) disease, also known as CD55-deficient protein-losing enteropathy

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