Regeneron Receives Complete Response Letter on the BLA for Aflibercept to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, and Diabetic Retinopathy
Shots:
- Based on the ongoing review of inspection findings at a third-party filler, the US FDA granted a CRL for the BLA filed by the company for aflibercept (8mg) as a treatment option for patients with wAMD, DME & DR
- There were no issues identified with the clinical efficacy, safety, trial design, labeling, or drug substance manufacturing for aflibercept & no additional trial data were requested
- The regulatory filings for aflibercept in Europe & Japan are currently under review whereas the company also expects to submit data for aflibercept to other regulatory bodies across other countries. Regeneron is jointly developing aflibercept along with Bayer
Ref: Regeneron | Image: Regeneron
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
