The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab).
Oxurion NV, which had spent much of 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in part B of the phase II Kalahari study.
On the heels of the U.S. FDA clearance for Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. to treat Chaple disease, the regulatory rollercoaster ride for the firm’s bid with higher-dose Eylea (aflibercept) ended with a green light for that compound as well. Eylea HD is indicated for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
The U.S. FDA has approved its second treatment for an ultra-rare disease in the past three days by greenlighting Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. Approval of the priority BLA for Veopoz, a fully human monoclonal antibody to treat Chaple disease, was announced two days ahead of its Aug. 20 PDUFA date. It is the only FDA-approved therapy for the indication.
Success in two pivotal studies of high dose Eylea (aflibercept) has significantly strengthened Regeneron Pharmaceuticals Inc.’s market position. But the company will face stiff competition from biosimilars and Roche Holding Group’s recently approved Vabysmo. After struggling for much of the year, the Tarrytown, N.Y.-based company’s stock (NASDAQ: REGN) rose about 20% this week. It closed 2% upward on Sept. 9 at $724.32 per share.
Shares in Oxurion NV dropped 40.3% percent May 9 on news that one of its two clinical-stage assets, THR-687, failed to demonstrate efficacy in a phase II trial in diabetic macular edema (DME). The candidate, a small-molecule pan integrin receptor antagonist, failed to demonstrate efficacy in Part A of the trial, called Integral, in which treatment-naïve patients received one of two doses of THR-687.
After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
A number of possible mechanisms have been explored, but there is still no safe, reliable and universally applicable method for delivering drugs across the blood-brain barrier (BBB) to treat central nervous system diseases. Now researchers have succeeded in tuning the effect of methamphetamine, a cause of BBB breakdown, enabling brain penetration of small molecules and therapeutic proteins, without damaging the epithelial cells that constitute the main physical element of the barrier.
At the end of March, JAMA Ophthalmology’s publication of first results from the NIH-sponsored, 328-patient trial with Regeneron Pharmaceuticals Inc.’s VEGF inhibitor, Eylea (aflibercept), in non-proliferative diabetic retinopathy bolstered investor hopes for wider use. But competitors loom for the compound, first approved in November 2011 for wet age-related macular degeneration.
