Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta, a first-in-class complement inhibitor, slows estimated glomerular filtration rate (eGFR) decline by 48% versus placebo over two years. This approval converts an initial accelerated approval granted in August 2024 for the reduction of proteinuria in primary IgAN.

The approval was based on data from the Phase III APPLAUSE-IgAN study. Results demonstrated a statistically significant and clinically meaningful improvement in eGFR over two years. Fabhalta showed an annualized mean change from baseline in eGFR of -3.0 mL/min/1.73 m²/yr compared with -5.7 mL/min/1.73 m²/yr for placebo. Clinically meaningful improvements in protein in urine were observed as early as two weeks, with sustained reduction over the treatment period.

Safety profile and access

The APPLAUSE-IgAN study indicated that Fabhalta has a favorable safety profile, consistent with previously reported data. The most common adverse events in patients with IgAN were abdominal pain, dizziness, and nausea. Fabhalta may increase the risk of serious infections caused by encapsulated bacteria and is available only through a Risk Evaluation and Mitigation Strategy (REMS) program requiring appropriate vaccinations prior to treatment.

Novartis is committed to helping IgAN patients access Fabhalta through support programs, with nearly 100% of US patients paying $10 or less per month. The company’s growing IgAN portfolio includes Vanrafia (atrasentan) and the investigational compound zigakibart.

Mechanism of action

Fabhalta is an oral Factor B inhibitor designed to selectively target the alternative complement pathway. This pathway is a key driver of inflammation associated with IgAN. By inhibiting Factor B, the drug aims to reduce ongoing complement-mediated injury and slow disease progression. Fabhalta has received regulatory approvals in multiple complement-mediated diseases and is being evaluated across a range of rare kidney conditions.

The open offer for Novartis India Limited by a consortium of acquirers concluded with minimal acceptance from public shareholders. WaveRise Investments Limited, ChrysCapital Fund X, and Two Infinity Partners, collectively referred to as the Acquirers, successfully acquired only 40 equity shares out of the 64,19,608 shares offered. The offer was made at a price of ₹860.64 per share.

The Acquirers, along with Persons Acting in Concert (PACs) ChrysCapital X, LLC and OceanEdge Investments Limited, had previously secured a significant stake in Novartis India Limited through agreements. Prior to the open offer, the group acquired 1,74,50,680 shares, representing 70.68% of the voting share capital. This included 1,39,38,382 shares by WaveRise Investments Limited and 25,47,189 shares by ChrysCapital Fund X.

Post-Offer Shareholding Details

The public tendering for the open offer was negligible, with only 182 shares tendered in total. Following the acceptance of 40 shares, the post-offer shareholding of the Acquirers and PACs stands at 1,74,50,720 shares. Consequently, the shareholding of public shareholders adjusted marginally to 72,40,077 shares, representing 29.32% of the voting share capital.

Regulatory Compliance and Publication

Axis Capital Limited, the manager to the offer, submitted the post-offer advertisement to BSE Limited on July 10, 2026. The advertisement, dated July 9, 2026, was published in Financial Express, Jansatta, and Navshakti to comply with Regulation 18(12) of the SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011. MUFG Intime India Private Limited acted as the registrar to the open offer.