The US Food and Drug Administration has approved Jascayd (nerandomilast) tablets for the treatment of a rare and progressive lung disease, idiopathic pulmonary fibrosis. Approval was supported by data from two randomized, double-blind, placebo-controlled trials in adults with idiopathic pulmonary fibrosis. The primary endpoint in both studies was the absolute change from baseline in forced vital capacity. Patients receiving Jascayd experienced a statistically smaller decline in forced vital capacity compared with those given a placebo.

The recommended dosage of Jascayd is 18 mg administered orally twice daily, approximately 12 hours apart. For patients with treatment intolerance, the dosage may be reduced to 9 mg twice daily, except in those concurrently receiving pirfenidone.

The most common adverse events (≥5%) included diarrhea, COVID-19, upper respiratory tract infection, depression, decreased weight and appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.

Source: FDA