Boehringer Ingelheim earns USFDA approval for Jascayd tablets for progressive pulmonary fibrosis
Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has approved JASCAYD (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults.
This represents a new treatment option in the U.S. for this debilitating lung condition, with JASCAYD being the preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. The FDA approval is based on results from the pivotal Phase III FIBRONEERTM-ILD clinical trial, the largest clinical trial program in PPF to date. Results showed that nerandomilast effectively slowed lung function decline in PPF with similar permanent discontinuation rates 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, M.D., Prof., 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.”
The primary endpoint in FIBRONEERTM-ILD was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at Week 52.5 Nerandomilast demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo. Specifically, the adjusted mean decline in absolute change from baseline in FVC in patients receiving nerandomilast 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group. The respective treatment difference compared with the placebo group was 65 mL (95% CI: 30, 101) and 83 mL (95% CI: 48, 118). The most common adverse reactions in patients with PPF treated with nerandomilast were generally consistent with those observed in patients with IPF.
“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need. The U.S. 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."
