The US FDA approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), the first new therapy approved in more than 10 years for IPF.
RT’s Three Key Takeaways:
- FDA Approval Milestone – The US FDA has approved Jascayd (nerandomilast) tablets for idiopathic pulmonary fibrosis (IPF), marking the first new IPF therapy in over a decade.
- Clinical Efficacy – In two randomized, double-blind, placebo-controlled trials, Jascayd significantly slowed lung function decline, as measured by reduced loss of Forced Vital Capacity (FVC), compared with placebo.
- Dosage and Safety – The recommended dose is 18 mg twice daily, with possible reduction for intolerability, and common side effects include diarrhea, fatigue, decreased appetite, and nausea.
The US FDA approved Jascayd (nerandomilast) tablets (PDF) to treat idiopathic pulmonary fibrosis (IPF), the first new therapy approved in more than 10 years for IPF.
IPF affects the tissue surrounding the air sacs, or alveoli, in the lungs. It develops when this lung tissue becomes thick and stiff. Over time, these changes can cause permanent lung scarring (fibrosis) that makes it more difficult to breathe. The most common symptoms are shortness of breath and cough. IPF progression varies, and scarring may happen slowly or quickly. Many people with IPF also experience acute exacerbations, in which symptoms suddenly intensify. IPF is diagnosed most often in people in 60 to 70 years of age.
The efficacy of Jascayd was evaluated in two randomized, double-blind, placebo-controlled trials of adults with IPF. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC) — the maximum amount of air a person can forcefully exhale after taking the deepest possible breath — Individuals taking Jascayd had a significantly smaller FVC decline when compared with placebo-treated patients.
In September, Boehringer Ingelheim revealed data from Phase 3 clinical trials of nerandomilast, showing nominally significant reduction in risk of death across IPF and PPF, as well as slowing lung function decline in IPF and PPF, with similar discontinuation rates to placebo.
The recommended dosage for Jascayd is 18 mg orally twice a day, approximately 12 hours apart. Jascayd dosage may be reduced for intolerability to 9 mg twice daily, except in patients also taking pirfenidone.
The most common side effects (≥5%) associated with Jascayd are diarrhea, COVID-19, upper respiratory tract infection, depression, weight decreased, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
