Ingelheim, Germany
Boehringer Ingelheim’s JASCAYD® (nerandomilast) has been approved by China’s National Medical Products Administration (NMPA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients. This is the first approval in IPF in over a decade and comes only two weeks after being approved by the Food and Drug Administration (FDA) in the United States.
“IPF has long been a difficult disease to diagnose and manage, marked by a progressive decline in lung function and a profound impact on patients’ daily lives,” said Professor Xu Zuojun, chief physician of the Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital. “As the first innovative therapy in over a decade to achieve the primary endpoint in a Phase III clinical trial, nerandomilast not only demonstrates significant clinical efficacy but also offers favorable tolerability. We look forward to seeing this innovative therapy benefit more patients soon, providing a novel solution in the fight against this disease.”
The approval in China is based on the pivotal Phase III clinical trial, FIBRONEERTM-IPF, the largest Phase III study conducted to date in the field of IPF treatment. Results showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo.1,2 FVC is a key measure of lung function3, and the findings indicate that the drug effectively slows the decline in lung function in IPF patients.1,2 Furthermore, as monotherapy, nerandomilast demonstrated a favorable tolerability and safety profile with discontinuation rates comparable to placebo.2,4
“Today’s approval of nerandomilast in China is a breakthrough for people living with idiopathic pulmonary fibrosis—a disease defined by relentless loss of lung function and a heavy burden on patients and families,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This milestone reflects our commitment to pioneering innovation for those who need it most.”
A regulatory submission for nerandomilast in progressive pulmonary fibrosis (PPF) is also under review with the National Medical Products Administration (NMPA) of China.
About nerandomilast
Nerandomilast is an oral, preferential inhibitor of PDE4B approved for the treatment of IPF in adult patients. Nerandomilast was approved by the U.S. Food and Drug Administration (FDA) after securing Priority Review and Breakthrough Therapy Designation and is under priority review by the FDA for the treatment of adults with PPF.
Regulatory submissions for nerandomilast in IPF are also under review in Japan and the EU, with filings in other geographies to follow.
About IPF
IPF is one of the more common progressive fibrosing interstitial lung diseases.5 IPF substantially impacts quality of life and half of patients succumb to the disease within five years of diagnosis.6 In IPF, the root cause of pulmonary fibrosis is not known.5 Symptoms and signs of IPF include a dry and persistent cough, shortness of breath, fatigue and finger clubbing (widening and rounding of the topics of the fingers).7 IPF may affect up to 3.6 million people worldwide.8 The disease primarily affects people over the age of 50 and affects more men than women.9
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.
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