Global pharma giant Boehringer Ingelheim has secured US FDA approval for JASCAYD (nerandomilast) tablets to treat progressive pulmonary fibrosis (PPF) in adults. This marks a major new option for patients with this debilitating lung disease. 

 

JASCAYD is the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved for PPF in the US.

 

The approval is based on results from the Phase III FIBRONEERTM-ILD clinical trial, the largest trial ever conducted in PPF. The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo.

 

“Progressive pulmonary fibrosis is linked to underlying clinical ILD diagnoses including autoimmune ILDs – which can be caused by disorders like rheumatoid arthritis or systemic sclerosis – as well as hypersensitivity pneumonitis, among other conditions,” said Shervin Assassi, Director of Rheumatology, McGovern Medical School, UTHealth Houston. 

 

"These underlying conditions often lead to the lungs being overlooked, yet lung scarring may lead to debilitating and irreversible impact on lung function. This can have a detrimental effect on patients’ lives and highlights the need for new treatment options that can help reduce the decline in lung function, as has been observed with nerandomilast.”

 

In the trial, the primary endpoint was the absolute change in Forced Vital Capacity (FVC) from baseline at Week 52. Patients taking nerandomilast experienced a significantly smaller decline in FVC compared to placebo: -86 mL and -69 mL for the 18 mg and 9 mg doses, respectively, versus -152 mL in the placebo group. 

 

“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The US approval of JASCAYD is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. 

 

"My gratitude goes to patients, investigators and our teams whose dedication made this milestone possible. We will now work closely with stakeholders to enable access and work tirelessly to ensure patients around the world can benefit from JASCAYD as quickly as possible.”

 

“People living with progressive pulmonary fibrosis often carry a heavy burden that others don’t always see,” said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. “A progressive disease condition process like PPF can worsen lung function quickly, and patients have been eagerly awaiting additional treatment options. The FDA approval of nerandomilast for PPF is a welcomed milestone for the community.”