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news.China’s National Medical Products Administration (NMPA) has granted approval to Boehringer Ingelheim’s Jascayd (nerandomilast) as an oral treatment for idiopathic pulmonary fibrosis (IPF) in adults.
The drug showed safety and favourable tolerability as a monotherapy, with discontinuation rates similar to placebo. Credit: National Cancer Institute on Unsplash.
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This comes just two weeks after its US Food and Drug Administration (FDA) approval.
The approval is based on results from FIBRONEER-IPF, a Phase III trial in IPF treatment. Nerandomilast achieved its primary endpoint, showing an absolute change in Forced Vital Capacity (FVC) over 52 weeks compared with placebo.
FVC is a principal measure of lung function, and the results indicate nerandomilast helps slow lung function decline in IPF patients.
The drug also showed safety and favourable tolerability as a monotherapy, with discontinuation rates similar to placebo.
Boehringer Ingelheim managing directors board chairman and human pharma head Shashank Deshpande said. “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.
“This milestone reflects our commitment to pioneering innovation for those who need it most.”
A regulatory submission for progressive pulmonary fibrosis (PPF) is under review with NMPA.
Nerandomilast is also under priority review in the US for adults with PPF.
Submissions for nerandomilast in IPF are pending in the EU and Japan, with further filings planned globally.
IPF is a progressive lung disease affecting an estimated 3.6 million people globally, predominantly those over the age of 50 and more men than women.
Symptoms include finger clubbing, fatigue, breathlessness and persistent cough. The cause of pulmonary fibrosis remains unknown.
