Boehringer Ingelheim’s Jascayd Wins FDA Approval as First New IPF Therapy in Over a Decade

The FDA has approved Boehringer Ingelheim’s Jascayd (nerandomilast) tablets as the first new treatment option in over a decade for idiopathic pulmonary fibrosis (IPF), a progressive and life-limiting lung disease affecting about 100,000 Americans. Jascayd is a twice-daily, oral PDE4B inhibitor shown to significantly slow the decline in lung function compared to placebo in clinical trials, delivering new hope for patients and clinicians facing a condition with few effective options.

Approval was based on data from two large Phase 3 trials where adults treated with Jascayd experienced a smaller reduction in forced vital capacity (FVC), the measure of lung capacity, compared to placebo patients at 52 weeks. Jascayd also demonstrated a well-tolerated safety profile, with the most common side effects being gastrointestinal symptoms such as diarrhea, as well as upper respiratory tract infections. The drug works by selectively blocking phosphodiesterase 4B, an enzyme involved in inflammation and fibrosis—addressing both scarring and immune pathways in IPF.

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