The United States has filed a complaint against Regeneron Pharmaceuticals, alleging that the company fraudulently manipulated Medicare reimbursement for its drug, Eylea, by knowingly submitting false average sales price (ASP) reports to Medicare. The complaint alleges that Regeneron inflated Eylea’s ASP by paying credit card processing fees for the benefit of physician-customers purchasing Eylea, without properly reporting these payments as price concessions to ASP, resulting in hundreds of millions of dollars in inflated reimbursements by Medicare. The government's investigation was prompted by False Claims Act allegations brought in a whistleblower lawsuit, and if found liable, Regeneron could face significant financial penalties.
The Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' high-dose Eylea, a treatment for three eye diseases, earlier than expected. The approval is seen as crucial for Regeneron to maintain market share in the face of competition from Novartis' Vabysmo. Analysts predict that Eylea could bring in billions of dollars in sales from 2023 to 2025. The approval also helps Regeneron fend off biosimilar competition and potential drug price negotiations, extending its market share for two to three years. Shares of Regeneron rose 3.9% following the news.
The U.S. Food and Drug Administration (FDA) has approved a higher dose version of Regeneron Pharmaceuticals' drug Eylea for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The higher dose, known as Eylea HD, is priced at $2,625 per single-use vial in the U.S. and has been shown to be as effective as the lower dose version in late-stage trials. The FDA had previously declined to approve the higher dose version due to outstanding questions regarding a third-party manufacturer, but those issues have now been addressed.
The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' drug, Veopoz (pozelimab), for the treatment of CHAPLE disease, a rare blood disease. Veopoz is the first FDA-approved treatment for this life-threatening condition and will be available in the U.S. in the third quarter of this year. CHAPLE disease affects fewer than 10 patients in the U.S. and less than 100 worldwide. However, the drug comes with a boxed warning for serious meningococcal infections. Additionally, Regeneron stated that the approval of Veopoz has resolved pre-approval inspection issues related to the higher dose of its blockbuster eye disease drug, Eylea (aflibercept). The FDA's decision on the 8mg dose of Eylea is expected soon, which could help preserve Regeneron's Eylea franchise and future revenues.
The US Food and Drug Administration (FDA) rejected Regeneron Pharmaceuticals' application for a stronger formulation of its eye medicine Eylea due to ongoing inspection findings at a Catalent Inc. production facility in Bloomington, Indiana. Catalent confirmed that its facility was the one in question and stated that it is taking the observations seriously and working on proposed corrective actions. This is the latest setback for Catalent, which has faced previous inspection-related issues impacting the supply of Moderna's Covid booster shot and Novo Nordisk's weight-loss drug Wegovy. The delay in approval could be costly for Regeneron, as it faces potential competition from cheaper versions of Eylea next year.
Regeneron Pharmaceuticals' stock slumped after the FDA rejected its application for approval of a higher-dose version of its popular eye disease treatment, Eylea.
The FDA rejected Regeneron's new 8-mg version of Eylea due to an ongoing review of inspection findings at a third-party filler, dealing a major blow to the company's attempt to expand the use of its eye injection for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company had sought to speed up the FDA's review of this application with a priority review voucher, which typically costs about $100 million.
