The U.S. Food and Drug Administration (FDA) has granted approval to Boehringer Ingelheim’sJASCAYD® (nerandomilast) tablets as an oral treatment option for adult patients with idiopathic pulmonary fibrosis (IPF), a rare, progressive, and debilitating chronic condition characterized by a continuous decline in lung function and a five-year survival rate lower than many common cancers. JASCAYD® (nerandomilast) tablets as an oral treatment option for adult patients with idiopathic pulmonary fibrosis (IPF), a rare, progressive, and debilitating chronic condition characterized by a continuous decline in lung function and a five-year survival rate lower than many common cancers.

Nerandomilast is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved for this indication, representing a novel mechanism of action that provides both antifibrotic and immunomodulatory effects to slow the decline in lung function.

This milestone is considered a pivotal moment, marking the first time the treatment landscape for IPF, which affects an estimated 200,000 people in the U.S., has evolved in over a decade.

The FDA's decision is supported by data from two clinical trials, including the FIBRONEER™-IPF trial, which demonstrated a statistically significant reduction in the decline of Forced Vital Capacity (FVC)—a key measure of lung function—in patients treated with nerandomilast compared to placebo. Specifically, at week 52, patients receiving 18 mg of nerandomilast experienced an adjusted mean FVC decline of -106 mL, a significantly smaller decline when compared to the -170 mL seen in the placebo group. This treatment effect was observed as early as week two and continued to diverge over the course of the study. Healthcare professionals view nerandomilast as a welcome new option with a well-tolerated safety profile. The most common adverse reactions reported more frequently than placebo included diarrhea (42% in the 18 mg group), upper respiratory tract infection, COVID-19, and depression. Discontinuation due to adverse reactions was infrequent, with diarrhea being the most common cause, leading to discontinuation in 6% of patients on the 18 mg dose. With no "Warnings and Precautions" section in the FDA-approved label, nerandomilast provides an important addition to the care landscape for people living with IPF.