The U.S. Food and Drug Administration has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults.
Jascayd becomes the first and only preferential phosphodiesterase 4B inhibitor with immunomodulatory and antifibrotic effects approved for this indication.
The approval is based on results from the pivotal phase 3 FIBRONEER-ILD clinical trial, in which treatment with Jascayd led to a significantly smaller reduction in forced vital capacity (FVC) decline compared with placebo. From baseline, the absolute change in adjusted mean decline of FVC was -86 mL and -69 mL for patients receiving Jascayd 18 and 9 mg, respectively, compared with -152 mL in the placebo group. Adverse events led to permanent discontinuation of the trial regimen in 10.0% and 8.1% of patients receiving Jascayd 18 and 9 mg, respectively, versus 10.2% in the placebo group.
“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need,” said Shashank Deshpande, the head of Human Pharma at Boehringer Ingelheim, in a statement. “The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with progressive pulmonary fibrosis, providing a new, well-tolerated treatment option.”
Approval of Jascayd was granted to Boehringer Ingelheim.
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