Welcome to HCPFIVE, your go-to roundup for the latest healthcare news and breakthroughs is specifically curated for busy health professionals.
Each week, we highlight five important developments or headlines from healthcare that you need to know. Whether it's cutting edge treatment, regulatory updates, or innovations that will shape the future of medicine. This week's top story focused on the US Food and Drug Administration (FDA) will focus on nephrology and ophthalmology, including a priority review of the Pegcetaco Plan for Rare Kidney Disease. Sozinibelpus in angiogenesis (wet) age-related macular degeneration (AMD).
Using HCPFIVE gives you important points to provide information and stay in front of the curve. You can easily dive into the top stories of the week of March 30th, 2025.
Interested in oncology news? Check out oncfive from the sisters' publication Onclive.
FDA accepts C3G, IC-MPGN PEGCETACOPLAN (Empaveli) SNDA
The FDA accepted and granted priority review for the Supplementary News (SNDA) of Apellis Pharmaceuticals in Pegcetacoplan (Empavei) for C3 glomerular disorders (C3G) and primary immune complex membranous inflammatory glomerulosis (IC-MPGN). Supported by positive 26-week results from the Phase 3 Valiant exam, SNDA was assigned a target action date of July 28, 2025.
Opthea announces the end of Sozinibercept's coast and coastal trials
Sozinibercept is a novel vascular endothelial growth factor (VEGF) “trap” fusion protein intended to treat wet AMD, and has failed to demonstrate the visual acuity improvement required for success in phase 3 coastal trials. Opthea has decided to finish both coastal and coastal testing and stop the development of Sozinibercept on wet AMD.
Atrasentan (Vanrafia) receives accelerated approval for IGA nephropathy
The FDA has given accelerated approval to Novartis' atlasentan (Vanraffia), a non-steroidal, oral treatment, once a day, to reduce proteinuria in adults with primary IgA nephropathy (IGAN), at risk for rapid disease progression. The approval is the first mark of the FDA, an endothelin that selects receptor antagonists to reduce igan proteins, and adds armor for growing treatments of the kidneys.
FDA issues a complete response letter to Reproxalap for dry eye disease
The FDA has issued a complete response letter (CRL) for the resubmission of the new drug application (NDA) of Reproxalap, a topical eye treatment for dry eye disease (DED). The FDA cited that it cannot demonstrate efficacy in appropriate, well-controlled studies treating eye symptoms associated with dry eyes. Pending discussion with the FDA, Aldeyra Therapeutics plans to resubmit the NDA by mid-2025, when a six-month review period is expected.
FDA approves inebilizumab (Uplizna) as the first IgG4-RD therapy in adults
The FDA has approved Amgen's Inebilizumab-Cdon (Uplizna) as the first and only treatment for adult patients diagnosed with immunoglobulin G4-related disease (IGG4-RD). Approval was awarded for positive findings from mitigation trials, with an 87% reduction in IgG4-RD flare compared to placebo over 52 weeks.
