EMA CHMP opinion recommends authorisation of Jascayd (nerandomilast) for IPF and PPF
The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of a marketing authorisation in the EU for Ja…
Impact analysis · 40/100 · AI-assisted priority
This score prioritizes research; it does not predict an outcome. Method and limitations.
What happened
The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of a marketing authorisation in the EU for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. The CHMP opinion is an intermediate procedural step, which will be sent to the European Commission for a binding decision on an EU‑wide marketing authorisation.
Quantitative evidence
- 2,355 patients across two studies
- FVC decline: IPF placebo 183 ml vs Jascayd 18 mg twice daily ~115 ml and 9 mg ~139 ml
- FVC decline: PPF placebo ~166 ml vs Jascayd 18 mg ~99 ml and 9 mg ~85 ml
- p‑values or confidence intervals not provided
- mortality reduction quantified data unavailable
Affected entities
Analysis
The following contextual analysis is AI-assisted and separated from the reported primary-source record above.
Scientific context
Jascayd is a novel PDE4B inhibitor that slows fibrosis and inflammation by reducing FVC decline in IPF and PPF patients.
Market context
As a first-in-class oral treatment for both IPF and PPF, Jascayd could fill a major unmet need in a high‑mortality indication; Boehringer Ingelheim is the applicant.
Legal and regulatory context
This is a CHMP opinion recommending EU marketing authorisation; the recommendation now awaits a European Commission binding decision.
Sources
For informational use only. Verify decisions against the linked regulator or primary source.
Evidence & limits
Source: Open the source record
- Record identifier
- d0147c52b4a36cb1d606e902cbb62290aec5ebc9f622d695346a21c5db9dae1f
- Event / action date
- Not separately retained
- Source update date
- Not separately retained
- Platform retrieval / processing date
- 2026-05-22T130911Z
What it supports. The linked authority’s action, within the product, indication, jurisdiction, and procedural stage stated in that record.
Limits. A committee opinion, draft, or announcement does not by itself establish final authorization. The summary and contextual analysis are AI-assisted; a source link does not establish human review.
Connection basis. Related profiles are normalized name mentions in article text. A mention does not establish a legal relationship.