Higher-dose Eylea gets swift US nod following recent CRL

2023-08-20

上市批准临床3期临床结果

The FDA has approved a higher-dose version of Regeneron Pharmaceuticals' Eylea (aflibercept) for patients with wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and diabetic retinopathy (DR). The decision marks a swift turnaround from June when the US regulator issued a complete response letter for Eylea 8mg citing an ongoing review of inspection at third-party manufacturer Catalent.

The approval also comes on the heels of another FDA nod for a Regeneron drug – the C5 antibody branded Veopoz (pozelimab-bbfg) to treat CHAPLE disease. With Veopoz's approval, Regeneron hinted that a positive decision for Eylea 8mg could be forthcoming as pre-approval inspection issues that had led to the June CRL were now addressed.

Regeneron said the latest clearance was based on 48-week results of the pivotal PULSAR and PHOTON trials. Last year, the company and partner Bayer reported that the primary endpoint was met in both Phase III trials – PULSAR in wet AMD AMD and PHOTON in DME – with high-dose Eylea demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens, compared to an eight-week dosing regimen using the drug's original 2mg version.

Regeneron noted that the vast majority of patients randomised at baseline to high-dose Eylea were able to maintain the 12- and 16-week dosing intervals through 48 weeks. The recommended dose for Eylea 8mg is monthly injections for the first three months across all indications, followed by every eight to 16 weeks in wAMD and DME, and every eight to 12 weeks for DR.

The most common adverse reactions, occurring at a rate of ≥3%, in patients on the high-dose version of Eylea were cataract, conjunctival haemorrhage, higher intraocular pressure, ocular discomfort, blurred vision, vitreous floaters, vitreous detachment, corneal epithelium defect and retinal haemorrhage.

Regeneron maintains exclusive rights to Eylea, including the high-dose version, while Bayer has licensed exclusive marketing rights outside of the US, where the companies share equally in profits from sales of the drug. Regulatory filings for Eylea 8mg are under review in Europe and Japan, with submissions also planned in other markets.

Analysts have said an approval of the higher-dose version of Eylea could provide Regeneron a defence against rivals such as Roche's Vabysmo (faricimab-svoa), which won US approval early in 2022 to treat both wet AMD AMD and DME. Roche's bispecific antibody, designed to block pathways involving Ang-2 and VEGF-A, allows less frequent dosing than standard therapy with Eylea 2mg.

For related analysis, see Regeneron eyes key drug approval in Q3 and Physician Views Results: Ophthalmologist feedback shows Roche’s Vabysmo in rude health.

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