August 9, 2026

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August 9, 2026

Newsletter

The European Post

Policy • Diplomacy • Strategic Insight

LATEST
New EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully PayAir Passenger Rights Get Their First Overhaul in Two DecadesErasmus Opens a 5 Billion Euro Round for Skills and MobilityCeuta Crisis Pushes the EU Toward Faster Migrant ReturnsBulky Parcels Face a Packaging Crackdown From August 12Can Europe Build Its Drone Wall Before 2030 Arrives?Indonesia’s Trade Deal With Europe Nears Its Final SignatureEurope Leans on Beijing to Keep Climate Talks Alive Before AntalyaNew EU Gas Market Rules Take Effect With Consumer SafeguardsDeforestation Regulation Holds Its December Deadline Despite CutsDigital Omnibus Delays Europe’s High-Risk AI Deadline to 2027Europe’s Schools Confront a Widening Basic Skills GapRule of Law Report Finds Progress but Trust Still LagsIRIS2 Gains 66 Satellites as Brussels Signs the Rollout DealNature Restoration Plans Come Due as Member States Race a DeadlineECB Rates Hold at 2.25 Percent as Frankfurt Waits on the DataEU Budget Talks Turn to Cohesion as Ireland Takes OverWildfire Response Stretches Europe’s Emergency Fleet ThinCan Europe’s Quantum Plan Match Its Big Ambitions?Armenia Edges West as Moscow’s Grip Slips AwayEurope Inherits the World’s Aid Bill It Cannot Fully PayAir Passenger Rights Get Their First Overhaul in Two DecadesErasmus Opens a 5 Billion Euro Round for Skills and MobilityCeuta Crisis Pushes the EU Toward Faster Migrant ReturnsBulky Parcels Face a Packaging Crackdown From August 12Can Europe Build Its Drone Wall Before 2030 Arrives?Indonesia’s Trade Deal With Europe Nears Its Final SignatureEurope Leans on Beijing to Keep Climate Talks Alive Before Antalya

CHMP Backs Nerandomilast Path Toward EU Pulmonary Fibrosis Use

Rudolf Nureyev
Parliament Reporter, Health and Wellbeing

The Committee for Medicinal Products for Human Use cleared eight new medicines at its 18-21 May meeting, but the file that has drawn most clinical attention is the positive opinion on Jascayd, the brand name under which Boehringer Ingelheim is bringing the PDE4B inhibitor nerandomilast through European authorisation. The drug is recommended for adults with idiopathic pulmonary fibrosis and for adults with progressive pulmonary fibrosis, two conditions that have together resisted the introduction of any genuinely new therapeutic class for the better part of a decade.

The clinical case rests on the FIBRONEER-IPF and FIBRONEER-ILD phase three programmes, which together showed that nerandomilast reduced the annual rate of forced vital capacity decline against placebo, with the benefit holding whether or not patients were already on the existing antifibrotic backbone of pirfenidone or nintedanib. That add-on profile is what shifts the European treatment conversation. Pulmonary fibrosis specialists have for years argued that the existing antifibrotics slow disease progression without arresting it, and combination regimens have been improvised in clinical practice without a formal evidence base. A second molecule with a different mechanism, designed and trialled with combination use in mind, changes the planning horizon for both prescribers and payers.

Regulatory sequencing matters here. The US Food and Drug Administration approved nerandomilast for idiopathic pulmonary fibrosis in October 2025 and extended the indication to progressive pulmonary fibrosis in December 2025. China, the United Arab Emirates and Japan followed earlier in 2026. The CHMP opinion is therefore not a first-mover decision; it is a convergence on what other major regulators have already validated, but with the additional weight that European pricing and reimbursement architectures attach to a centralised authorisation. The Commission decision normally follows the CHMP opinion within around sixty-seven days, which would put marketing authorisation into late July or early August.

The CHMP slate goes wider than the lung file. A conditional marketing authorisation was recommended for Vijoice, the alpelisib formulation indicated in severe PIK3CA-related overgrowth spectrum disorders, an ultra-rare indication that has previously been managed off-label or under compassionate use frameworks in most member states. Conditional authorisation is the mechanism the agency uses where unmet medical need is high and confirmatory data are still maturing, and the recommendation closes a long-running access gap for PROS patients who have had no centrally authorised option.

The committee also issued eighteen positive opinions on extensions of therapeutic indication, including label expansions on existing oncology and immunology products that will keep the workload on national HTA bodies high through the summer. Health technology assessment timelines remain the bottleneck most often cited by patient organisations: a positive CHMP opinion only matters in clinical practice once national agencies have completed their cost-effectiveness reviews and reimbursement decisions, a process that can run from six months in faster jurisdictions to more than two years in the slowest. The Joint Clinical Assessment framework, applicable to medicines for advanced therapies and oncology since January 2025, is meant to compress that timeline, and Jascayd will be among the early stress tests of whether centralised clinical evaluation actually shortens patient access for non-oncology files.

For respiratory medicine specifically, the pipeline behind nerandomilast is thin. No comparable late-stage candidate is expected to read out before 2027, which means the practical decisions over the next twelve months — formulary placement, combination protocols, monitoring requirements — will define the European standard of care for both fibrotic indications for some time.

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