Boehringer Ingelheim’s Jascayd (Nerandomilast) tablets has been approved by the US Food and Drug Administration (FDA) as an oral treatment option for Idiopathic Pulmonary Fibrosis (IPF) in adult patients. Jascayd is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.

“This milestone represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast has proven to slow lung function decline in IPF. Nerandomilast is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients,” said Toby Maher, MD, Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles.

The FDA approval is based on data from two clinical trials: FIBRONEER-IPF (NCT05321069) and Trial 2 (NCT04419506). The primary endpoint in FIBRONEER-IPF was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at week 52. Nerandomilast demonstrated a significantly smaller FVC decline compared to placebo. Specifically, the adjusted mean decline in patients receiving 18 mg or 9 mg Nerandomilast was -106 mL and -122 mL, respectively, versus -170 mL in the placebo group. Additionally, a treatment effect was shown as early as week two with Nerandomilast 18 mg compared to placebo, with changes from baseline in FVC continuing to diverge over time to week 52.

“The FDA approval of Nerandomilast is a pivotal moment for people living with IPF as this marks the first time in over 10 years that the treatment landscape is evolving. This new step forward, driven by the compelling results of the FIBRONEER-IPF trial, underscores our unwavering commitment to change the way we treat IPF by delivering innovative therapies like Nerandomilast,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head–Human Pharma, Boehringer Ingelheim.

The most common (=5%) adverse reactions reported in patients treated with Nerandomilast and more frequently than the placebo group were as follows for Nerandomilast 18 mg, 9 mg and placebo, respectively: diarrhoea (42%, 31%, 17%), COVID-19 (13%, 16%, 12%), upper respiratory tract infection (13%, 11%, 10%), depression (12%, 11%, 10%), weight decreased (11%, 10%, 8%), decreased appetite (9%, 9%, 5%), nausea (8%, 9%, 7%), fatigue (7%, 8%, 6%), headache (7%, 6%, 5%), vomiting (6%, 5%, 5%), back pain (6%, 5%, 4%) and dizziness (5%, 6%, 5%).

Discontinuation due to adverse reactions occurred more frequently in patients treated with Nerandomilast (with or without background antifibrotic treatment) 18 mg (15%) and 9 mg (12%) compared to placebo (11%). The most frequent adverse reaction leading to discontinuation of Nerandomilast 18 mg and 9 mg was diarrhoea (6% and 2%, respectively).

There is no ‘Warnings and Precautions’ section in the FDA-approved product label. 

“The FDA approval of Nerandomilast is exciting news for people living with Idiopathic Pulmonary Fibrosis and their caregivers. There has been a long-standing need for new treatment options for IPF within our community and Nerandomilast provides an important addition to the care landscape,” said Scott Staszak, President and CEO, Pulmonary Fibrosis Foundation.

Nerandomilast is an oral, preferential inhibitor of PDE4B approved in the US for the treatment of IPF in adult patients. It was approved by the FDA after securing Priority Review and Breakthrough Therapy Designation.

Regulatory submissions for Nerandomilast in IPF are also under review in China, Japan and the EU, with filings in other geographies to follow.