FDA Issues CRL to Regeneron Over Manufacturing Issues of Eye-Disease DrugBy
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals, a Tarrytown, New York pharmaceutical company, regarding manufacturing issues relating to a prefilled syringe form of Eylea (aflibercept), a drug to treat age-related macular degeneration macular edema, and diabetic retinopathy.
Eylea had 2017 net product sales in the US of $3.7 billion. Regeneron has exclusive rights to Eylea in the US. Regeneron is partnered with Bayer on the global development and commercialization of Eylea outside the US. Bayer has exclusive marketing rights outside the US, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
The CRL related to the chemistry, manufacturing and controls (CMC) prior-approval supplement (PAS) for a prefilled syringe form of Eylea (aflibercept). The drug is now administered as a vial kit with injection components (filter needle, syringe, injection needle). The FDA’s CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea prefilled syringe in approximately 30 patients. Regeneron says it expects to compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the Eylea prefilled syringe.