|
FDA Approves Drug to Treat Chronic, Progressive Lung Disease
Action
The U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF). Jascayd was previously approved to treat idiopathic pulmonary fibrosis (IFP) in adults.
Disease or Condition
PPF is a chronic disease characterized by gradual, irreversible scarring of the lungs, which can lead to progressive breathing difficulties. PPF is an umbrella term that can describe progressive lung scarring in many interstitial lung diseases.
Data Supporting Jascayd
Jascayd’s efficacy for PPF was demonstrated in FIBRONEER-ILD (NCT05321082), a randomized, double-blind, placebo-controlled study that enrolled 1,178 adults with PPF. Participants were randomly assigned 1:1:1 to receive twice daily administration of Jascayd 9 mg, Jascayd 18 mg, or placebo for at least 52 weeks.
Patients treated with either dose of Jascayd showed significantly slower rates of lung function decline compared to placebo, based on the primary endpoint of absolute change in forced vital capacity (FVC) — the maximum amount of air a person can forcefully exhale after taking the deepest possible breath — at 52 weeks. The adjusted, average decline in patients receiving 18 mg or 9 mg Jascayd was -72 mL and -85 mL, respectively, whereas the placebo group had a -151 mL decline. Additionally, patients receiving Jascayd had fewer events of either interstitial lung disease exacerbations, respiratory hospitalizations, or death over the course of the trial.
The recommended dosages for Jascayd are 9 mg or 18 mg orally twice a day, approximately 12 hours apart.
Safety Information
The safety of Jascayd in patients with PPF was generally consistent with that observed in patients with IFP, a previously approved indication. Side effects include diarrhea, decreased weight, decreased appetite, and nausea. See the prescribing information for more safety information.
Designation
Jascayd received a Breakthrough Therapy Designation for the PPF indication.
|
