FDA Issues CRL for Extended Dosing of Eylea HD
The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.
The FDA has issued a complete response letter (CRL) for the supplemental biologics license application (sBLA) for the addition of extended dosing intervals for Eylea HD (aflibercept) injection 8 mg across all approved indications.
Eylea HD is approved with dosing intervals from every 8 to 16 weeks. Regeneron was seeking approval for extended dosing intervals of greater than every 16 weeks and up to every 24 weeks.
The CRL did not identify any issues with the safety or efficacy of Eylea HD, according to a press release from Regeneron. Company officials said they are evaluating the FDA’s decision. The company is not releasing any additional information.
Developed by Regeneron and Bayer AG, Eylea HD is approved for patients with neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. Additionally, an sBLA for Eylea HD is under review by regulators to treat patients with macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.
Eylea 2 mg is already approved to treat patients with macular edema after retinal vein occlusion, which is a blockage in a small blood vessel that carries blood away from the retina. Retinal vein occlusion is a common cause of vision loss in adults and the second most common retinal vascular disease.
The low-dose form of Eylea is also approved to treat patients with retinopathy of prematurity (ROP), neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. Eylea HD is approved for patients with neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy.
In 2024, U.S. sales of Eylea (low dose and HD combined) were $4.77 billion. Eylea 2 mg has a list price of $1,896.25 for a single-dose glass vial. Eylea HD 8 mg has a cost of $2,625.
Related: New Study Shows Extended-Dose EYLEA HD is Effective for wAMD and DME
The sBLA was based on data from the second year of the PHOTON and PULSAR studies. In these studies, Eylea HD demonstrated that it was non-inferior and achieved clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared with an Eylea 8-week dosing regimen after initial monthly doses. This study was done in patients with wet age-related macular degeneration and diabetic macular edema.
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