Following the recent approval of nerandomilast tablets for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, the FDA has approved the medication for progressive pulmonary fibrosis as well, according to a press release from manufacturer Boehringer Ingelheim.

Nerandomilast, marketed as Jascayd, is a preferential inhibitor of phosphodiesterase 4B with both immunomodulatory and antifibrotic effects, according to the press release.

The drug is the first of its kind to be approved for progressive pulmonary fibrosis (PPF), a life-threatening condition associated with underlying interstitial lung disease (ILD).

The approval was supported by data from the phase 3 FIBRONEER-ILD trial, in which nerandomilast significantly slowed lung function decline in adults with PPF over 52 weeks compared with placebo. In the study, approximately 1100 adults with PPF were randomized to 18 mg or 9 mg of nerandomilast twice daily, or placebo. The primary endpoint was an absolute change in forced vital capacity (FVC) in milliliters from baseline.

The adjusted mean change in FVC from baseline to 52 weeks in the 18 mg nerandomilast, 9 mg nerandomilast, and placebo groups were -86 ml, -69 ml, and -152 ml, respectively, with significant differences between both nerandomilast doses and placebo.

Nerandomilast was well-tolerated overall across both doses. Diarrhea was the most common adverse event and was more common among patients also taking nintedanib; 1% of patients not taking nintedanib discontinued the medication as a result of diarrhea. Serious adverse events were similar across all groups, according to the press release.

No significant differences appeared among the treatment and placebo groups in the key secondary composite endpoint of time to first occurrence of acute ILD exacerbation, hospitalization for any respiratory cause, or death.

Nerandomilast is now approved for both IPF and PPF in the US and China, and regulatory submissions are under review in the EU, the UK, Japan, and other countries, according to the company. Full prescribing information is available here.

The FIBRONEER study was supported by Boehringer Ingelheim.