Source – Regeneron
Regeneron’s highly anticipated high-dose version of Eylea has suffered an unexpected setback as the FDA rejected its approval due to manufacturing issues at a third-party drug filler, according to a statement from Regeneron. The rejection did not raise concerns about the drug’s efficacy, safety, labeling, or drug substance manufacturing, and no additional clinical data was requested.
Regeneron and its partner Bayer had submitted an application for the 8 mg Eylea (aflibercept) version in the hopes of gaining approval for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR), putting them in direct competition with Roche’s Vabysmo.
Despite this setback, Regeneron remains committed to collaborating closely with the FDA and the third-party filler to resolve the manufacturing issues and bring the high-dose drug to market. The company has not disclosed the identity or location of the filler.
It’s worth noting that the FDA recently issued a Form 483 against an Eli Lilly plant in Indianapolis for deficiencies identified during an inspection, and the agency also rejected Lilly’s ulcerative colitis treatment, mirikizumab, due to manufacturing-related shortcomings.
Regeneron’s high-dose Eylea has demonstrated exceptional efficacy in clinical trials, with results indicating that a significant percentage of patients maintained the dosing schedule over a two-year period. This data could give Eylea an advantage over Vabysmo in the market once the manufacturing issues are resolved. The high-dose version is still under review in Europe and Japan, and Regeneron plans to submit applications in additional countries.
Eylea may gain a competitive advantage over Vabysmo due to the new data, leading to a fierce market competition once Regeneron resolves the issues related to manufacturing. According to Regeneron’s statement, the high-dose version is currently being reviewed in Europe and Japan, and the company plans to submit it for approval in other countries as well.
