FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis

Core Viewpoint - Roche's supplemental new drug application (sNDA) for Gazvya (obinutuzumab) has been accepted by the FDA for potential treatment of lupus nephritis, with a final decision expected by October 2025 [1][2]. Drug Development and Regulatory Updates - The sNDA is backed by data from the late-stage REGENCY study, which demonstrated that patients receiving Gazvya in combination with standard therapy had a better complete renal response (CRR) compared to those on standard therapy alone [2]. - Roche plans to submit a similar regulatory filing to the EMA, also supported by REGENCY study data, with the drug marketed as Gazyvaro in the EU [3]. Financial Performance - Gazvya is a significant revenue driver for Roche, contributing CHF910 million in sales in 2024, reflecting a 16% year-over-year increase [6]. - Year-to-date, Roche's stock has increased nearly 22%, outperforming the industry growth of 12% [4]. Ongoing Research - In addition to lupus nephritis, Roche is exploring Gazyva in late-stage studies for other conditions, including membranous nephropathy and childhood-onset idiopathic nephrotic syndrome, with data expected next year [7].