The HCPFive: Top News for Healthcare Providers from the Week of 03/30

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories focused on US Food and Drug Administration (FDA) moves across nephrology and ophthalmology, including a Priority Review for pegcetacoplan in rare kidney diseases, a new approval in IgA nephropathy (IgAN), a Complete Response Letter (CRL) for reproxalap in dry eye disease (DED), and the first-ever treatment for IgG4-related disease—alongside the halted development of sozinibercept in neovascular (wet) age-related macular degeneration (AMD).

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 30, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

FDA Accepts Pegcetacoplan (Empaveli) sNDA for C3G, IC-MPGN

The FDA accepted and granted Priority Review to Apellis Pharmaceuticals' supplemental New Drug Application (sNDA) for pegcetacoplan (Empaveli) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). Supported by positive 26-week results from the phase 3 VALIANT trial, the sNDA was assigned a target action date of July 28, 2025.

Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept

Sozinibercept, a novel vascular endothelial growth factor (VEGF) “trap” fusion protein intended to treat wet AMD, failed to demonstrate the vision improvements required for success in the Phase 3 COAST trial. Opthea has decided to terminate both the COAST and ShORe trials and cease the development of sozinibercept in wet AMD.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

The FDA granted accelerated approval to Novartis’ atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression. Approval marked the FDA’s first for a selective endothelin A receptor antagonist for reducing protein in IgAN and adds to nephrology’s growing armamentarium of therapies.

FDA Issues Complete Response Letter to Reproxalap for Dry Eye Disease

The FDA issued a Complete Response Letter (CRL) for the resubmission of the New Drug Application (NDA) for reproxalap, a topical ocular treatment for dry eye disease (DED). The FDA cited the failure to demonstrate efficacy in adequate and well-controlled studies treating ocular symptoms associated with dry eyes. Pending discussions with the FDA, Aldeyra Therapeutics intends to resubmit the NDA for reproxalap by mid-2025, with an expected 6-month review period.

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults

The FDA 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 on positive findings from the MITIGATE trial, showing a reduction in IgG4-RD flares by 87% compared with placebo over 52 weeks.