Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults. PPF is a life-threatening lung condition that causes continuous decline in lung function and is associated with interstitial lung diseases such as autoimmune ILDs and hypersensitivity pneumonitis. The condition affects up to 100,000 people in the U.S. and up to 5.6 million worldwide.
JASCAYD is the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor approved for this indication, offering immunomodulatory and antifibrotic effects. The FDA approval is supported by results from the Phase III FIBRONEER™-ILD clinical trial, the largest study conducted to date in PPF, which demonstrated that JASCAYD effectively slows lung function decline compared to placebo.
“Progressive pulmonary fibrosis is a serious condition that significantly affects patients’ lives,” said Shervin Assassi, M.D., Professor and Director of Rheumatology at McGovern Medical School, UTHealth Houston. “JASCAYD provides a new treatment option that helps reduce lung function decline.”
The trial showed that patients taking JASCAYD experienced smaller declines in Forced Vital Capacity (FVC), a key measure of lung function, compared to placebo. The treatment was generally well-tolerated, with diarrhea being the most common side effect.
“This FDA approval is an important milestone in addressing the unmet medical need in PPF,” said Shashank Deshpande, Head of Human Pharma at Boehringer Ingelheim. “We remain committed to ensuring patients have timely access to this therapy.”
Patients and healthcare providers in the U.S. can access JASCAYD through Boehringer Ingelheim’s CareConnect4Me™ support program, which provides a range of patient access and clinical support solutions, including financial assistance. More information is available at JASCAYD.com or by calling 1-844-JASCAYD (1-844-527-2293).
About Boehringer Ingelheim
Boehringer Ingelheim is a global biopharmaceutical company dedicated to developing innovative therapies to improve and extend lives. Active since 1885, the company employs approximately 54,500 people and operates in over 130 markets worldwide.
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