Jascayd approval urged in EU for treating adults with 2 PF types
Drug now approved in Japan, providing 'treatment option' for IPF, PPF
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A regulatory committee of the European Medicines Agency is urging approval of the oral therapy Jascayd (nerandomilast) in the European Union for treating adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), two forms of the respiratory disease.
While the European Commission — which makes all final decisions on treatment approvals in the EU — does not have to follow the recommendations of the Committee for Medicinal Products for Human Use (CHMP), it nearly always does. The committee’s positive opinion was based primarily on the results of a large clinical trial testing the therapy, which was approved last year in the U.S. for both of these indications.
“The CHMP’s positive opinion for Jascayd reflects the growing recognition that meaningful efficacy alongside a well‑tolerated profile is essential for enabling sustained treatment in IPF and PPF,” Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, which markets the therapy, said in a company press release announcing the recommendation.
Deshpanded noted that, “if approved in the EU, Jascayd would mark the first new treatment option for IPF in Europe in more than a decade.”
Earlier this month, the medication — film-coated tablets typically taken twice daily — was approved for the same indications in Japan.
“With Jascayd, physicians in Japan now have a new oral treatment option … that can support sustained treatment, helping more patients stay on therapy and face the future with greater confidence,” Deshpande said in a separate press release announcing that approval.
Pulmonary fibrosis is characterized by lung inflammation and scarring (fibrosis), leading to symptoms such as shortness of breath and dry cough. In IPF, the most common form of the disease, the exact causes of lung scarring are unknown. In PPF, lung scarring progressively worsens over time.
“Current treatments for IPF and PPF, including in patients whose PPF is associated with underlying autoimmune rheumatic diseases, have well‑known limitations. This is why advancing therapies with new mechanisms of action and better tolerability profiles is essential to improving how we manage these complex diseases,” said Anna‑Maria Hoffmann‑Vold, MD, PhD, professor at the University of Zurich and Oslo University Hospital, and investigator in the FIBRONEER program.
New milestones supported by FIBRONEER trial data
Jascayd is designed to reduce inflammation and scarring by blocking the activity of an enzyme called phosphodiesterase 4B (PDE4B).
The positive regulatory decisions across different geographies have largely been based on results from two completed Phase 3 trials — FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) — showing the treatment slowed lung function decline and reduced the risk of death in IPF and PPF patients.
Collectively, the FIBRONEER trials assessed Jascayd’s safety and efficacy at two doses — 9 mg and 18 mg — given twice daily for as long as one year. Each trial enrolled more than 1,100 adults with either form of pulmonary fibrosis.
The FIBRONEER-IPF trial demonstrated that Jascayd was superior to a placebo at slowing lung function decline after one year of treatment in individuals with that PF type. Most participants were also receiving standard IPF medications, namely pirfenidone or nintedanib, which is sold as Ofev.
Regulatory applications in PPF, meanwhile, were supported by data from FIBRONEER-ILD, which also showed lung function decline after one year. Most patients were also receiving approved antifibrotic therapies.
Jascayd appears to reduce the risk of death in both conditions
A pooled analysis that used data from both studies showed that Jascayd appears to reduce the risk of death in people with either condition. The treatment also demonstrated a favorable safety profile.
“In the FIBRONEER trials, [Jascayd] was well‑tolerated and slowed lung function decline, supporting its potential for long‑term use,” Hoffmann‑Vold said. “This is imperative in conditions like IPF and PPF, including patients with an associated autoimmune rheumatic disease, which can worsen suddenly and unpredictably. Maintaining lung function for longer can therefore make a meaningful difference in clinical practice.”
The approval of Jascayd is a major achievement that has the potential to transform the treatment paradigm for … people living with IPF and PPF.
Regulatory submissions are now under review in the U.K. and other countries, with additional approvals anticipated this year, according to the developer.
Arata Azuma, MD, PhD, head of the department of respiratory medicine at Tokorozawa Mihara General Hospital in Japan, said “the introduction of Jascayd as a new treatment option offers great hope to people living with IPF and PPF” in that Asian nation.
“The approval of Jascayd is a major achievement that has the potential to transform the treatment paradigm for these conditions. With a novel mechanism of action that exerts both antifibrotic and anti-inflammatory effects in the lungs, Jascayd demonstrated a reduction in lung function decline,” Azuma said.
