早些时候报道：Vertex通过FDA针对IgAN的滚动审查推进了Povetacicept计划;启动OLYMPUS，这是一项关于Pove治疗pNN的2b/3期实质性研究，并宣布RUBY-3试验的更新日期，接受最新突破性的美国肾病学会2025年演讲

- Food and Drug Administration grants rolling review of Biologics License Application for povetacicept in IgA nephropathy; Vertex to submit first module before end of year -

- Second pivotal development program of povetacicept underway with Phase 2b/3 trial initiation in primary membranous nephropathy -

- Updated data from RUBY-3 trial of povetacicept accepted for late breaking oral presentation; inaxaplin study design and APOL1-mediated kidney disease related data accepted for poster presentation -

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases.

Next Steps for Pove Development

In IgAN

Following the announcement that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application (BLA) for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before the end of 2025. The Company remains on track to complete the full BLA submission for accelerated approval in the U.S. in the first half of 2026, if results from the planned interim analysis are supportive.

In pMN

Vertex announced it has initiated OLYMPUS, a Phase 2b/3 pivotal study of pove for the treatment of pMN, the second indication in which pove has best-in-class potential. There are no therapies specifically approved for the treatment of pMN.

"We are very pleased with the continued momentum in our pove program across multiple indications," said Carmen Bozic, M.D., Executive Vice President of Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. "Breakthrough designation, rolling submission for the IgAN BLA, and initiation of the second pivotal trial for pove, in pMN, bring us closer to getting this potential best-in-class therapy to patients with these serious diseases."

The company also announced upcoming presentations at the American Society of Nephrology (ASN) Kidney Week 2025, November 6-9 in Houston, Texas highlighting data from more patients with longer duration of follow up with pove in IgAN and pMN as well as data on the burden of disease in patients with APOL1-mediated kidney disease (AMKD).

Data to be Presented at ASN

Vertex will present data on adults with IgAN and with pMN who received pove subcutaneously every 4 weeks (SC Q4W) in the RUBY-3 trial, in addition to its poster presentations on inaxaplin and AMKD.

• A late-breaking presentation #SA-OR091, entitled "Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 Weeks of Treatment: The RUBY-3 Study," will be presented during Late-Breaking Research Orals-3 session on November 8 from 5:06–5:18 p.m. CST.
• A presentation #FR-PO0813, entitled "Povetacicept for IgAN: Design of a Phase 3 Randomized, Placebo-Controlled Study," will be presented during a poster session and via eposter on November 7 from 10:00 a.m. to 12:00 p.m. CST.
• A presentation #TH-PO0604, entitled "Inaxaplin for a Broad Population with APOL1-Mediated Kidney Disease and Comorbid Conditions: Phase 2 Proof-of-Concept Study," will be presented during a poster session and via eposter on November 6 from 10:00 a.m. to 12:00 p.m. CST.
• A presentation #TH-PO0625, entitled "Clinical Characteristics and Disease Progression Among Nondiabetic Patients with APOL1-Mediated Kidney Disease (AMKD) and Patients with Other Forms of Chronic Kidney Disease (CKD)," will be presented during a poster session and via eposter on November 6 from 10:00 a.m. to 12:00 p.m. CST.