Dave Singh, MD, reflects on 2027 GOLD report refinements, from mucus plugs and early COPD to biologics awaiting regulatory approval.
News|Articles|April 8, 2025
Q1 Sleep Medicine Updates
Author(s)Chelsie Derman
Q1 2025 sleep updates include FDA rejecting pitolisant NDA for idiopathic hypersomnia, iptacopan improving PNH fatigue, and more.
Advertisement
Advertisement
In the first quarter of 2025, sleep medicine saw a mix of regulatory shifts and promising clinical data. Although the US Food and Drug Administration (FDA) rejected the New Drug Application (NDA) for pitolisant in idiopathic hypersomnia, plans for a new registrational trial are underway.
Related to this article
Retrospective data show semaglutide 2.4 mg was linked to lower liver enzymes, weight, and HbA1c in MASH, including vs resmetirom in a real-world cohort.
Francesca Polverino, MD, PhD, explains how oxidized and reduced IL-33 drive mucus dysfunction and inflammation in COPD, and why mucus plugs matter.
Phase 2 ENHANCE and ENRICH data show BRII-179 plus elebsiran and peginterferon increased HBsAg loss in chronic HBV, with priming halving peginterferon use.
Pooled phase 2 data show fazirsiran 200 mg cut intrahepatic Z-AAT by about 90% vs placebo in AATD liver disease, with stable lung function through the OLE.
Once-monthly efimosfermin alfa reduced liver stiffness, ELF, and PRO-C3 through 52 weeks in MASH with F2–F4 fibrosis, including compensated cirrhosis.
Alvar Agustí, MD, previews key 2027 GOLD report changes, from initial COPD treatment and new biologic data to a GOLD Science Committee call to action.
In a phase 2 decentralized study, once-daily trientine tetrahydrochloride improved convenience and adherence in Wilson disease; 80% preferred it.
Advertisement
Advertisement