European Medicines Agency (EMA) has adopted a positive opinion recommending approval of nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in the European Union.

IPF and PPF are life-threatening, progressive interstitial lung diseases characterized by irreversible scarring of lung tissue, leading to declining lung function and worsening respiratory symptoms. Early diagnosis and continuous treatment remain critical to slowing disease progression and improving patient outcomes.

The positive CHMP recommendation is based on results from the Phase III FIBRONEER™ clinical trial program, which evaluated the efficacy and safety of nerandomilast in patients with IPF and PPF. The studies demonstrated clinically meaningful benefits with a safety and tolerability profile supportive of long-term treatment in these chronic fibrotic lung diseases.

Nerandomilast, marketed as JASCAYD®, is the first and only orally available preferential phosphodiesterase 4B (PDE4B) inhibitor approved for the treatment of IPF and PPF in the United States, China, the United Arab Emirates, and Japan. If approved by the European Commission, nerandomilast would become the first new therapy for IPF in more than a decade in the European Union.

“The positive CHMP opinion marks an important milestone for people living with IPF and PPF across Europe, where there remains a significant unmet need for innovative treatment options,” the company stated. “We are committed to advancing therapies that may help slow disease progression and improve the lives of patients affected by these devastating lung diseases.”

The European Commission will review the CHMP recommendation and is expected to make a final decision regarding marketing authorization in the coming months. If approved, nerandomilast would be authorized across all EU Member States, as well as Iceland, Liechtenstein, and Norway.