FDA does not approve aflibercept 8 mg
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Key takeaways:
- The FDA issued a complete response letter for aflibercept 8 mg.
- The rejection is due to a review of inspection findings at a third-party filler.
The FDA issued a complete response letter for the biologics license application for aflibercept 8 mg for the treatment of wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a press release.
The letter did not note any issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and the rejection is “solely due to an ongoing review of inspection findings at a third-party filler,” Regeneron said in the release.
The FDA did not request any additional clinical data or trials.
“Regeneron is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with [wet] AMD, DME and DR as quickly as possible,” according to the release.
Perspective
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The safety and efficacy data for aflibercept 8 mg submitted in the FDA registration package seemed consistent with a path to approval.
This rejection was due to a "3rd party filler," meaning an issue of how the actual drug vials are filled, without any criticism of the safety or efficacy of the aflibercept 8 mg data. This is a technical reason for the FDA's rejection in the complete response letter (CRL). I believe retina specialists will eventually have aflibercept 8 mg as an option, but it will take a few months to several months for Regeneron to work through this with the FDA.
For the retina space as a whole, I think this means that clinical researchers, prescribers, and pharmaceutical companies have to continue to be cognizant of every detail of an FDA submission, and that there is never a 100% chance of approval.
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