Iptacopan

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Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

FDA grants full approval to Travere Therapeutics’ Filspari (sparsentan) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN), supported by phase 3 PROTECT study results showing significant kidney function preservation over two years compared to irbesartan.

FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.

Travere Therapeutics' drug Filspari, for IgAN, received full FDA approval based on long-term data showing significant kidney function decline slowing. This expands the eligible patient population beyond initial proteinuria thresholds, potentially increasing market opportunity. Filspari competes with Novartis' Fabhalta and Calliditas' Tarpeyo, both also approved for IgAN. Filspari carries a black box warning for liver toxicity and is under a REMS program. Travere reported $46.9 million in Filspari revenue for H1 2024, with growth expected as approvals expand globally.

The FDA granted full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, removing the UPCR requirement. The approval includes boxed warnings for hepatotoxicity and birth defects, necessitating a REMS program and regular kidney function monitoring. Despite earlier data requests for FSGS treatment, the approval is based on the PROTECT trial's modified analysis showing Filspari's efficacy in slowing kidney function decline.

FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.

Novartis receives FDA accelerated approval for Fabhalta (iptacopan) to reduce proteinuria in primary IgA nephropathy (IgAN), targeting the alternative complement pathway. Approval based on Phase III APPLAUSE-IgAN study interim analysis showing 44% reduction in proteinuria at 9 months vs. 9% with placebo. Continued approval contingent on eGFR data expected in 2025.

Novartis received FDA accelerated approval for Fabhalta, a complement inhibitor for reducing proteinuria in adults with primary IgAN at risk of rapid progression. Continued approval depends on Phase III study results expected in 2025. IgAN is a rare, progressive kidney disease affecting about 25 per million annually.