FDA

FDA kicks Regeneron’s latest Eylea application to the curb, but they’re not sweating it

Regeneron $REGN says the FDA has rejected their application to sell a pre-filled syringe with Eylea, delaying a supplemental add-on that the biotech wants to safeguard its big blockbuster franchise from a rival. But the company was quick to spell out the reasons for the CRL, asserting that it can get things in line for regulators by early 2019.

Their statement:

The CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients. Regeneron expects to compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the Eylea pre-filled syringe.

Regeneron is aggressive about all things pipeline related, and with billions on the line it never gives an inch to Eylea’s challengers. Still, don’t look for anyone at the biotech to panic over this one.

Geoffrey Porges

Analysts and company officials have been pondering what the pre-filled syringe could do for Regeneron’s big drug. Back in August, Leerink’s Geoffrey Porges noted:

(M)anagement commented that Roche’s Lucentis pre-filled syringe has not caused a noticeable market share switch to Lucentis despite the assumed convenience of the new product. Further, management commented that Eylea is continuing to gain market share based on recent internal surveys even with the Lucentis pre-filled syringe on the market

Investigators paved the way to the bitter pill by coming up with a sweet batch of Eylea data to precede the kicker. In their PANORAMA study 80% and 65% of patients receiving Eylea every 8 or 16 weeks had a minimum 2-step improvement in diabetic retinopathy compared to only 15% for the placebo. 

Those numbers could broaden use of their drug in a key market.


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