European Commission approves JASCAYD® for IPF and PPF treatment in the EU
Saturday, July 18, 2026
The European Commission (EC) has granted marketing authorisation for JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), Boehringer Ingelheim announced.
The approval introduces the first new treatment for IPF in the European Union in more than 10 years and the first for PPF in over five years. JASCAYD® is the first oral preferential phosphodiesterase 4B (PDE4B) inhibitor approved for these conditions. The treatment is designed to slow disease progression while offering a favourable tolerability profile.
The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May and is based on findings from the Phase III FIBRONEER™ clinical programme, the largest trial programme conducted for IPF and PPF.
In both the FIBRONEER™-IPF and FIBRONEER™-ILD studies, nerandomilast met the primary endpoint by significantly slowing the decline in lung function, measured by the absolute change in forced vital capacity (FVC) from baseline to week 52, compared with placebo.
Although the key secondary endpoint was not achieved in either study, the trials showed a numerical reduction in mortality across both patient groups, with nominal significance reached in the FIBRONEER™-ILD study. The treatment also demonstrated a favourable safety and tolerability profile, with no requirement for routine liver monitoring. When used as monotherapy, treatment discontinuation rates were similar to those seen with placebo.
IPF and PPF affect more than 500,000 people across Europe. Both conditions cause progressive and irreversible scarring of the lungs, making breathing increasingly difficult. Around half of patients diagnosed with these diseases die within five years, giving them a poorer prognosis than many forms of cancer.
Current treatment options are often associated with side effects, including nausea, diarrhoea and sensitivity to sunlight, leading some patients to stop treatment early. In IPF, around half of those who discontinue treatment do so within six months of starting therapy.
According to Boehringer Ingelheim, the approval provides a new treatment option for people living with IPF and PPF and may help improve long-term treatment adherence by combining disease-modifying benefits with good tolerability.
Source: globenewswire.com
