Dive Brief:
Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue.

The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.”

Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said.

Dive Insight:
While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is already facing the prospect of generic competition in coming years as well as an immediate threat from the strong launch of Roche’s rival drug Vabysmo.

Eylea has long been Regeneron’s top seller, bringing in $6.3 billion in the U.S. last year. The eye injection helps protect vision and treat patients with a range of eye conditions, including wet age-related macular degeneration and diabetic macular edema. Regeneron says it’s been used more than 57 million times in patients worldwide.

Both Vabysmo and the higher dose version of Eylea are designed to give patients longer windows between needles. Patients on the currently approved dosage of Eylea need injections every eight weeks after an initial regimen; Vabysmo patients can get injections every four months. The higher-dose version of Eylea is comparable, with dosing every three or four months.

An approval of the higher dose version of Eylea on Tuesday – as expected – would have given Regeneron sales representatives more time to persuade doctors to stick with their product rather than move patients to Vabysmo. Regeneron also bolstered its case with new data showing that the longer treatment intervals for high-dose Eylea can be maintained for at least two years.

Now, the company has to wait. The setback “comes at a time when the Eylea franchise has little margin for error,” Piper Sandler analyst Christopher Raymond wrote to clients. While there’s no estimate for when the manufacturing issue would be resolved, analysts at RBC Capital Markets noted that other companies in similar situations have faced delays of seven to nine months.

Reference：
https://www.biopharmadive.com/news/regeneron-high-dose-eylea-fda-rejection-vabysmo/654115/