China’s National Medical Products Administration (NMPA) has approved Boehringer Ingelheim'S Jascayd (nerandomilast), an oral treatment for the lung disease idiopathic pulmonary fibrosis (IPF) in adults.
The NMPA granted approval due to positive results from the phase 3 Fibroneer-IPF trial. Treatment with both 18 mg and 9 mg of Jascayd for 52 weeks led to statistically-significant improvements from the baseline in forced vital capacity (FVC) compared to the placebo. The drug had been included for priority review by the Centre for Drug Evaluation (CDE) of the NMPA in January.
In the U.S., the FDA approved Jascayd just two weeks ago, making it the first treatment to receive approval for IPF in more than a decade. This approval was similarly based on clinical trials showing that the treatment slowed FVC decline.