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Regeneron’s high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection.  

The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release.

The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said.

In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said.

A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located.

Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in October. FDA staffers cited deficiencies at the facility’s drug filling lines. The agency in April also rejected Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls.

High-dose Eylea has shown stellar efficacy results, which analysts from RBC Capital Markets in September said will “likely support approvability and some degree of market conversion to high dose Eylea.”

Regeneron released new two-year data on the high-dose version almost simultaneously with the complete response letter announcement. The trial showed that 89% of patients given a dose intended to last 12 weeks maintained that schedule through the two years, while 83% assigned to the 16-week schedule maintained that regimen. By the end of two years, 43% of patients met the bar for a dosing interval that lasts over 20 weeks.

High-dose Eylea is “the first to demonstrate that patients with diabetic macular edema can immediately be treated with every 12- or 16-week dosing after their initial monthly doses and experience lasting vision control,” said Regeneron’s president and chief scientific officer George Yancopoulos, M.D., Ph.D.

The new data could give Eylea an edge on Vabysmo, setting it up for a heated market battle once Regeneron sorts out the manufacturing hiccups. The high-dose version is still under review in Europe and Japan, with planned submissions in additional countries, Regeneron noted in its statement.