2:50 PM
Apr 15, 2019
 |  BC Extra  |  Company News

FDA accepts BLA for Novartis' AMD therapy

Novartis said FDA accepted for review a BLA for brolucizumab to treat wet age-related macular degeneration. The pharma said it used a Priority Review voucher for the application, but declined to disclose details about the voucher.

Novartis AG (NYSE:NVS; SIX:NOVN) hopes to launch the next-generation, humanized single-chain anti-VEGF antibody fragment in the U.S. by year end.

In both the Phase III HAWK and HARRIER trials, more than half of patients who received brolucizumab remained on an every 12-week dosing schedule, which Novartis has said suggests brolucizumab could offer an advantage over Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) (see "Novartis Details Brolucizumab Wet AMD Data").

Eylea's U.S. label says patients may be treated with every 12-week doses after a year of "effective therapy", while noting that the 12-week regimen is "not as effective as the recommended every 8 week dosing regimen" (see "FDA Approves 12-Week Eylea Regimen after Short Delay").

Bayer AG (Xetra:BAYN) has ex-U.S. rights to Eylea from Regeneron. The drug is a human fusion protein that binds all forms of VEGF-A and PGF.

Novartis announced the BLA acceptance after market close. Regeneron was off $7.44 to $375.50 on Monday.

Targets: PGF (PLGF) - Placental growth factor; VEGF - Vascular endothelial growth factor; VEGF-A - Vascular endothelial growth factor A

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