FDA Approves Expanded Label for Jascayd for PPF

Boehringer Ingelheim’s Jascayd (nerandomilast) has been given an expanded label by the U.S. Food and Drug Administration (FDA) to include use in adults with progressive pulmonary fibrosis (PPF), just months after being approved for idiopathic pulmonary fibrosis (IPF).

Approval is based on results from the Phase III FIBRONEER-ILD trial in which patients on the oral PDE4B inhibitor experienced a smaller decline in forced vital capacity (FVC) after a year than those receiving placebo, the trial’s primary endpoint. Adjusted mean FVC declines were 86 mL with the 18-mg dose and 69 mL with the 9-mg dose, compared with a 152-mL decline in the placebo arm, translating into treatment differences of 65 mL and 83 mL, respectively.

For secondary outcomes, the trial did not meet a key composite endpoint that measured time to the first occurrence of any of the components of the composite up to 109 weeks: time to acute exacerbation of interstitial lung disease (ILD), respiratory hospitalizations or death. An exploratory analysis did, however, show a nominally significant reduction in acute ILD exacerbations with the higher dose.

Meanwhile, a broader pooled analysis combining data from FIBRONEER-ILD and the companion FIBRONEER-IPF study also suggested Jascayd was associated with a nominally significant reduction in all-cause mortality risk in patients with IPF and PPF.

The “U.S. approval…is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” said Shashank Deshpande, head of human pharma at Boehringer.