European Commission approves Boehringer's JASCAYD for IPF and PPF

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The European Commission has granted marketing authorization to Boehringer Ingelheim's JASCAYD, a first-in-class oral PDE4B inhibitor, for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. This is the first new IPF treatment approved in the EU in over a decade and the first for PPF in more than five years. The approval is based on the FIBRONEER Phase III program, the largest clinical trial program in these conditions to date, where nerandomilast slowed lung function decline versus placebo and showed a favorable safety and tolerability profile with monotherapy discontinuation rates similar to placebo. IPF and PPF affect more than 500,000 people across Europe and carry a prognosis worse than many cancers, with about half of patients dying within five years of diagnosis. Boehringer Ingelheim noted that regulatory submissions are under review in other countries with additional approvals anticipated in 2026.

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EU approval of first-in-class IPF/PPF drug JASCAYD, a major product milestone.

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