FDA Grants Approval for JASCAYD® Tablets to Treat Progressive Pulmonary Fibrosis

FDA Approves JASCAYD® for Progressive Pulmonary Fibrosis

On December 22, 2025, the U.S. Food and Drug Administration (FDA) officially approved JASCAYD® (nerandomilast) tablets as a treatment option for adults diagnosed with progressive pulmonary fibrosis (PPF). This new approval marks a significant advancement for individuals struggling with this life-threatening condition, which is characterized by a relentless decline in lung function.

Understanding Progressive Pulmonary Fibrosis (PPF)

PPF affects a substantial number of people, with estimates suggesting around 100,000 cases in the United States and approximately 5.6 million globally. The condition is often associated with other forms of interstitial lung disease (ILD), particularly autoimmune diseases such as rheumatoid arthritis and systemic sclerosis, as well as hypersensitivity pneumonitis. Unfortunately, many patients with PPF remain undiagnosed for extended periods, compounding the issue of treatment access.

The recent FDA approval for JASCAYD represents the second indication for this medication, following its prior authorization for idiopathic pulmonary fibrosis (IPF). This dual approval is significant as it provides an essential therapeutic option for patients suffering from both conditions, highlighting the overarching need for effective treatments for progressive forms of lung disease.

Clinical Trials and Efficacy of JASCAYD

The approval of JASCAYD is founded on the comprehensive results of the Phase III FIBRONEER™-ILD clinical trial, which stands out as the largest clinical program focused on PPF to date. The trial demonstrated that JASCAYD effectively slows the decline in lung function, a critical factor in the management of PPF. Specifically, patients receiving JASCAYD saw a smaller reduction in Forced Vital Capacity (FVC) compared to those given a placebo, showing adjusted mean declines of -86 mL and -69 mL for the higher and lower doses of JASCAYD, respectively, in contrast to -152 mL in the placebo group.

These promising results were accompanied by acceptable safety profiles similar to the prior indications for JASCAYD, with diarrhea being the most frequently reported adverse reaction. While some patients did experience treatment discontinuation due to adverse effects, the rates for the JASCAYD groups were comparable to those of the placebo group, presenting a relatively well-tolerated treatment option for PPF patients.

Expert Opinions on the Approval

Healthcare professionals have voiced their enthusiasm regarding the approval and its implications. Dr. Shervin Assassi from McGovern Medical School emphasized the importance of JASCAYD in addressing the often-overlooked respiratory complications associated with autoimmune disorders that culminate in PPF. Additionally, Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim, articulated the unmet medical need addressed by this treatment and expressed gratitude to all stakeholders who made the approval possible.

Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation, underscored the relief felt by the PPF community upon learning about JASCAYD's approval, noting that patients had long been eager for more treatment options capable of extending and improving their quality of life.

Looking Ahead: Access to Treatment

Boehringer Ingelheim, the company behind JASCAYD, has committed to ensuring patient access through initiatives like CareConnect4Me™, designed to provide comprehensive support, including assistance with treatment costs. This patient-centric approach aims to maximize the impact of JASCAYD in improving patient outcomes across the U.S.

In conclusion, the FDA's approval of JASCAYD for the treatment of progressive pulmonary fibrosis signifies a hope-filled milestone for patients affected by this grievous lung disease. As the medical community prepares for the introduction of this innovative therapy, ongoing research and collaborations will be crucial in optimizing treatment pathways and improving the lives of those living with PPF.