The European Commission (EC) has granted marketing authorisation for Boehringer Ingelheim’s Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF).
This marks the first new treatment approved in IPF in the EU in over a decade and for PPF in more than five years. As a first-in-class oral preferential phosphodiesterase 4B (PDE4B) inhibitor, nerandomilast addresses a critical unmet need by successfully slowing disease progression while remaining tolerable.
The EC approval follows the positive CHMP opinion received in May and is based on results from a phase 3 trial, the largest clinical trial programme conducted in IPF and PPF to date.
IPF and PPF affect more than 500,000 people across Europe, causing irreversible lung scarring that severely restricts breathing.
Despite the life-threatening nature of these conditions, where approximately half of those diagnosed lose their lives within five years – a prognosis worse than many cancers – many people delay or stop existing therapies due to side effects such as nausea, photosensitivity, and diarrhea. In IPF specifically, approximately half of those who stop therapy do so within six months.
