Regulatory eyes on Regeneron: US FDA issues CRL for Eylea

By Flora Southey contact

- Last updated on GMT

(Image: Getty/serdarcan)
(Image: Getty/serdarcan)

Related tags: Fda, Regeneron, Novartis

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.

Related topics: Markets & Regulations, Cell lines

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