The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets, developed by Boehringer Ingelheim, for the treatment of idiopathic pulmonary fibrosis (IPF) — a rare, progressive, and life-threatening lung disease with limited treatment options and no known cure. This marks the first new FDA-approved therapy for IPF in more than 10 years.
Understanding Idiopathic Pulmonary Fibrosis
IPF affects the tissue surrounding the air sacs (alveoli) in the lungs, causing it to become thick and stiff over time. This leads to permanent lung scarring (fibrosis), making breathing increasingly difficult. Common symptoms include shortness of breath and chronic cough.
The disease typically affects individuals aged 60 to 70 years, and its progression can vary — with lung scarring occurring either gradually or rapidly. Many patients also experience acute exacerbations, during which symptoms worsen suddenly.
Clinical Data Supporting Jascayd
The efficacy of Jascayd was established through two randomized, double-blind, placebo-controlled trials involving adults with IPF. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC) — the maximum amount of air a person can exhale after a deep breath.
Results showed that individuals treated with Jascayd experienced a significantly smaller decline in FVC compared to those who received a placebo.
The recommended dosage is 18 mg orally twice daily, taken approximately 12 hours apart. For patients who experience intolerability, the dose may be reduced to 9 mg twice daily, except in those also receiving pirfenidone.
Safety Profile
The most common side effects (≥5%) reported with Jascayd include diarrhea, COVID-19, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
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