The US Food and Drug Administration (FDA) approved the chemistry manufacturing and controls (CMC) prior-approval supplement (PAS) for the Eylea (aflibercept) injection pre-filled syringe.
According to Regeneron, the 2mg single-dose sterilized pre-filled syringe is expected to be available by the end of 2019. George Yancopoulos, president and chief scientific officer at Regeneron stated, “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”
In October 2018, Regeneron’s prior-approval supplement for its Eylea pre-filled syringe was denied by the FDA. The agency stated that it was unable to approve the chemistry, CMC prior-approval supplement in the state it was in.
The FDA requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the pre-filled syringe in 30 patients.
Yancopoulos stated, regarding the recent approval, that the company has now completed eight pivotal Phase III trials.
Eylea is approved to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The injection is a vascular endothelial growth factor inhibitor formulation as an eye injection.
Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking the vascular endothelial growth factor and placental growth factor which are both involved in angiogenesis.
Additional regulatory roadblocks
In August 2018, Eylea was rejected by the FDA and Regeneron was issued a complete response letter (CRL) regarding “ongoing labelling discussions.”
However, four days after issuing the company a CRL, the FDA approved the supplemental biologics license application for Eylea, with a 12-week dosing schedule.