Sometimes, the devil is in the details when it comes to the rollout of a new drug.
In May 2019, Regeneron received FDA expanded approval for Eylea as a treatment for diabetic retinopathy. It took four months longer for the FDA to approve a prefilled syringe for the drug.
The FDA had initially rejected Regeneron’s prior-approval supplement for the Eylea prefilled syringes in October 2018, months before it ruled in favor of Eylea’s expanded use, out of concerns related to the chemistry of the drug delivery proposed. Within its response to the supplement, the FDA requested additional data, including figures from a usability study of the prefilled syringes.
Since that time, Regeneron completed supplementary research and supplied a sufficient amount of new data to satisfy the concerns of federal health regulators. With the new FDA approval in hand, Regeneron expects to make the Eylea prefilled syringes available for health care providers to use by the end of 2019, according to a BioPharma Reporter report. In a press release, Regeneron President and Chief Scientific Officer George D. Yancopoulos said the approval may make it easier for doctors to provide Eylea for patients.
Even without the prefilled syringes, Eylea ranks as the sixth-best-selling drug treatment in the world, according to a BioSpace report. It is one of the only injectables currently approved by the FDA specifically to slow the progression of diabetic retinopathy. Regeneron enjoys a market advantage with Eylea partly because it has the option of a lengthier approved dosing schedule (4 weeks or 8 weeks) than the drug’s market rival, Lucentis (4 weeks).
The FDA is currently considering the application of an additional drug that would be similar to Eylea and Lucentis – brolucizumab, which is being developed by Novartis.
These drugs comprise a class compounds called vascular endothelial growth factor (VEGF) inhibitors. These drugs slow or prevent the growth of new retinal blood vessels and the movement of fluid through eye vessels, both of which can cause serious vision complications.
In a 2017 T1D Exchange Glu poll, just over 32% of respondents said they had been diagnosed with retinopathy. Better access to drug therapy to treat this potentially debilitating condition could prove a real asset to the type 1 diabetes community.