Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 2 min read
17/07/2026
European Commission approved JASCAYD® as a treatment option for IPF and PPF in the EU (Ref)
Boehringer Ingelheim announced that the European Commission had granted marketing authorization for JASCAYD® (nerandomilast; PDE4B inhibitor) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF).
The EC approval was based on positive Phase 3, FIBRONEER™-IPF and FIBRONEER™-ILD trial.
Both trials met the primary endpoint, significantly slowing lung function decline (FVC) over 52 weeks versus placebo.
The key secondary endpoint was not met; however, a numerical reduction in mortality was observed across both trials (nominally significance in FIBRONEER™-ILD).
Nerandomilast demonstrated a favorable safety and tolerability profile, with no liver monitoring was required and discontinuation rates as monotherapy were comparable to placebo.
Novartis received FDA traditional approval for Fabhalta® for the treatment of primary IgAN. (Ref)
Novartis announced that the US FDA had granted traditional approval for Fabhalta® (iptacopan; an oral Factor B inhibitor) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
Fabhalta® received approval under a priority review designation, following initial FDA accelerated approval in August 2024 for the reduction of proteinuria in primary IgAN.
The approval was based on data from the Phase 3, APPLAUSE-IgAN study.
Fabhalta slowed eGFR decline by 48% vs placebo over two years, demonstrating kidney function preservation.
Clinically meaningful improvements in protein in urine were observed as early as two weeks, with sustained reduction over the treatment period.
The APPLAUSE-IgAN study showed that Fabhalta has a favorable safety profile, consistent with previously reported data.
