Boehringer Ingelheim Gets USFDA Nod for Jascayd Tablets

Boehringer Ingelheim got the green light from the U.S. Food and Drug Administration (FDA) for JASCAYD (nerandomilast) tablets, allowing the addition of a new oral drug to the treatment modalities of adult patients with idiopathic pulmonary fibrosis (IPF).

JASCAYD is a selective phosphodiesterase 4B (PDE4B) inhibitor supercharging a new mechanistic concept that merges the antifibrotic and immunomodulatory facets for retention of lung function in IPF patients.

“This landmark event heralds IPF therapy a completely new epoch,” said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “Nerandomilast has showed effectiveness in slowing lung function decline, thus, it's a good-tolerated drug choice for the suitable patients that physicians can use.”

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The Food and Drug Administration endorsement is attributable to the clinical trials results of FIBRONEER-IPF (NCT05321069) and Trial 2 (NCT04419506). FIBRONEER-IPF saw nerandomilast impeding the decrease of Forced Vital Capacity (FVC) at 52 weeks to a significant degree in comparison with the placebo.

Shashank Deshpande, Boehringer Ingelheim, Chairman and Head of Human Pharma, states "Indeed, the major first step in over ten years which culminates in the present Boehringer Ingelheim submission, and in our most recent breakthrough in IPF therapy, is represented by this approval.  It confirms our consistent pledge of highly innovative solutions to the problems of our patients as well as to healthcare providers and payers.