UPDATE: Aug. 17, 2018: On Friday, Regeneron Pharmaceuticals announced the Food and Drug Administration approved the supplemental Biologics Licensing Application (sBLA) for 12-week dosing of Eylea in wet age-related macular degeneration (AMD). The announcement came four days after Regeneron said it received a Complete Response Letter (CRL) regarding the application.
- It should take the FDA about two more months to make a final approval decision on a longer-dose version of Regeneron's Eylea, according to a Monday statement from the big biotech.
- That's the estimate from Regeneron after the FDA slapped the biotech's sBLA for a 12-week dose of Eylea in wet (AMD) with a CRL. The drug holds multiple eye disease indications, and is currently administered at either 4-week or 8-week intervals.
- Regulators accepted the sBLA for 12-week Eylea back in December and set a target action date for Aug. 11. Though Regeneron gave few details in an Aug. 13 statement, it did pin the CRL on "ongoing labeling discussions" between the company and the FDA — discussions it expects to wrap up in the next couple months.
Regeneron has been able to push Eylea (aflibercept) ahead of rival eye drug treatments like Roche's Lucentis (ranibizumab) and Avastin (bevacizumab), yet its market position isn't cemented.
Roche, for instance, is working on a refillable device that would allow for continuous administration of a special ranibizumab concentration. In July, the Swiss pharma said the device is going into late-stage testing after Phase 2 data showed a majority of wet AMD patients implanted with it went at least six months before needing a refill of the drug.
Novartis and Allergan are threats as well.
The former plans to file its VEGF inhibitor, brolucizumab, for approval this year. The drug has already demonstrated non-inferiority to Eylea in Phase 3 studies of wet AMD patients and, perhaps most importantly, notched positive data at a 12-week dosing schedule.
Allergan also recently released late-stage data that found a 12-week dosing regimen of its investigational treatment abicipar was non-inferior to an 8-week dosing regimen of Lucentis in treating wet AMD.
Eylea remains Regeneron's largest source of revenue, bringing in almost $1 billion in net product sales in the U.S. every quarter. Given that position, Regeneron hasn't sat idly by as competitors make inroads.
The New York-based biotech is working on a device similar to Roche's that executives estimate could launch in 2019.
"In the fairly comprehensive survey data we use of physician prescribing, it would suggest that we're continuing to see share growth with Eylea opposite Lucentis," Marion McCourt, head of Regeneron's commercial organization, said on the company's Aug. 2 second quarter earnings call.
"And certainly over the lifecycle of the brand, as Eylea has grown, we've taken equal share, about 20 market share points, both from Lucentis and from Avastin. So while we do think having a pre-filled syringe available ... will be helpful to physicians, we don't see it as in any way a negative to our current profile in marketplace as we're competing."
Another key strategy is expanding Eylea's label to include 12-week dosing. Yet the FDA's rejection raises questions on when that plan might come to fruition.