Regulatory eyes on Regeneron: US FDA issues CRL for Eylea

14-Aug-2018 - Last updated on 15-Aug-2019 at 15:08 GMT

(Image: Getty/serdarcan)

The US Food and Drug Administration has rejected Regeneron’s eye candidate, Eylea, but the biotech says it expects a final regulatory decision within two months.

According to Regeneron, “ongoing labelling discussions” prompted the US Food and Drug Administration’s (FDA’s) complete response letter (CRL) for Eylea (afibercept).

Eylea injection is a vascular endothelial growth factor inhibitor, designed for patients with wet age-related macular degeneration. “It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels – vascular permeability – the eye,” the firm explained in a statement.

The firm expects FDA labelling discussions to close, and to “receive a final FDA action”, within 60 days.

The regulatory setback comes just comes just months after Novartis instigated legal action against Regeneron, claiming the biotech breached manufacturing intellectual property laws. According to Novartis, Eylea infringes on its Lucentis (ranibizumab) patents.

Regeneron firm did not respond to a request for comment ahead of publication.

Regeneron nests in with bluebird

Earlier this month, Renegeron announced a partnership with bluebird bio, to develop six cell therapy candidates. According to the terms, Regeneron will take a $100m (€86.2m) stake in bluebird bio common stock, with the firms sharing R&D costs for the six investigational therapies.

If the new drug applications are approved by the FDA, Regeneron have the option to co-develop and co-commercialise the drugs with bluebird bio.