- JASCAYD is the first PDE4B inhibitor approved for progressive pulmonary fibrosis.
- PPF affects up to 100,000 in the U.S. and 5.6 million globally.
- FDA approval is based on the Phase III FIBRONEER-ILD trial.
- Nerandomilast showed a smaller FVC decline compared to placebo.
FDA Approval
The U.S. FDA has approved JASCAYD (nerandomilast) tablets for treating progressive pulmonary fibrosis (PPF) in adults. This marks the second FDA-approved indication for JASCAYD, following its approval for idiopathic pulmonary fibrosis (IPF).
Impact of PPF
PPF is a severe lung condition linked to interstitial lung diseases like autoimmune ILD and hypersensitivity pneumonitis. It affects up to 100,000 people in the U.S. and 5.6 million worldwide, causing a continuous decline in lung function.
Clinical Trial Results
The FDA's decision is based on the Phase III FIBRONEER-ILD trial, the largest clinical trial program for PPF. Nerandomilast demonstrated a significantly smaller reduction in Forced Vital Capacity (FVC) decline compared to placebo, with adjusted mean declines of -86 mL and -69 mL for 18 mg and 9 mg doses, respectively, versus -152 mL for placebo.
Expert Insights
Dr. Shervin Assassi highlighted the link between PPF and underlying ILD diagnoses, emphasizing the need for treatments that reduce lung function decline. The trial results showed nerandomilast's potential in addressing this need.
