The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).
The letter is based on a continuing assessment of inspection data at a third-party filler.
No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical trial, labelling or production of drug substance were noted in the CRL.
The regulatory agency also did not seek any further clinical findings or trials.
Submissions to European and Japanese regulators for the product are being reviewed currently.
The company is also planning to make submissions to various other regulators in other countries.
Co-developed by Regeneron and Bayer, aflibercept is investigational therapy. The efficacy and safety of the therapy is not approved by any regulator yet.
Regeneron holds the complete rights to Eylea (aflibercept) injection and aflibercept 8mg in the US region while Bayer has the licence to market the products outside of this region.
Outside of the US, the firms will split profits from sales of Eylea as well as aflibercept 8mg sales, which is contingent on obtaining regulatory approvals in the future.