The U.S. Food and Drug Administration (FDA) has approved Boehringer’s JASCAYD® (nerandomilast tablets) for adult patients with idiopathic pulmonary fibrosis (IPF).
- Nerandomilast is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication, representing a novel mechanism of action with antifibrotic and immunomodulatory effects.
- Nerandomilast is the first new treatment option to be approved for adults with IPF in more than a decade.
- IPF is one of the more common progressive fibrosing interstitial lung diseases that affects up to 3.6 million people worldwide, and an estimated 200,000 people in the U.S.
- While the cause of IPF is unknown, it can lead to substantial impacts on quality of life, with half of patients succumbing to the disease within five years of diagnosis.
Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles:
“Today’s milestone represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast is a welcomed new treatment option for physicians to consider for patients, with a well-tolerated safety profile and no requirements for liver or lab monitoring.”
Disease or condition
IPF affects the tissue surrounding the air sacs, or alveoli, in the lungs. It develops when this lung tissue becomes thick and stiff. Over time, these changes can cause permanent lung scarring (fibrosis) that makes it more difficult to breathe. The most common symptoms are shortness of breath and cough.
IPF progression varies, and scarring may happen slowly or quickly. Many people with IPF also experience acute exacerbations, in which symptoms suddenly intensify. IPF is diagnosed most often in people in 60 to 70 years of age.
Data supporting Jascayd
The efficacy of Jascayd was evaluated in two randomised, double-blind, placebo-controlled trials of adults with IPF. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC) — the maximum amount of air a person can forcefully exhale after taking the deepest possible breath.
Individuals taking Jascayd had a significantly smaller FVC decline when compared with placebo-treated patients.
The recommended dosage for Jascayd is 18 mg orally twice a day, approximately 12 hours apart. Jascayd dosage may be reduced for intolerance to 9 mg twice daily, except in patients also taking pirfenidone.
Safety information
The most common side effects (≥5%) associated with Jascayd are diarrhoea, COVID-19, upper respiratory tract infection, depression, decreased weight, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
Today’s approval furthers the FDA’s longstanding commitment to support treatment options for patients and advances in health care for the American public.
09.10.2025.
SOURCE
https://content.govdelivery.com/accounts/USFDA/bulletins/3f61959
Tereza Urbankova
Corporate Communications, Corp. Affairs
Boehringer Ingelheim Corporate Center GmbH
PHOTO: FREEPIK
