Shots:
- The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings planned
- Approval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts for atleast or over 52wks.
- Trial met its 1EP, showing reduced FVC decline at 52wks. (-106 mL & -122 mL vs -170 mL), with the 18 mg dose demonstrating benefit as early as Wk. 2 & sustained divergence through Wk. 52
Ref: Boehringer Ingelheim| Image: Boehringer Ingelheim | Press Release
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