title: The future of the development of medicines in idiopathic pulmonary fibrosis.
abstract: The development of treatments for idiopathic pulmonary fibrosis (IPF) has been often disappointing. Building on authorized treatments that can benchmark the validity of treatment effect measures, the time has come to standardize endpoints and achieve consensus on their use for different clinical questions and specific IPF phenotypes. In order to facilitate the development of new medicines for IPF it is crucial that the knowledge of the disease and lessons learnt from past trials are taken forward to create international trial networks with involvement of patients, including biobanks and clinical data collection through a multinational registry. Interaction with regulators may be useful to align the initiatives of academia and pharmaceutical companies with the bodies ultimately responsible for licensing new products. Interaction can occur through the use of qualification programs for biomarkers and endpoints, and participation in innovative regulatory pathways and initiatives. Finally, the experience of IPF should be used to benefit even rarer interstitial lung diseases for which no treatment is available, including pediatric interstitial lung diseases. This commentary provides a perspective on the hurdles slowing the development and regulatory approval of medicines for IPF, and encourages close cooperation between investigators and drug regulators.
authors.affiliation: Orphan Medicines Office, European Medicines Agency, 30 Churchill Place, Canary Wharf, E14 5EU, London, UK. Laura.Fregonese@ema.europa.eu.
authors.forename: Laura
authors.initials: L
authors.lastname: Fregonese
authors.affiliation: Paediatric Medicines Office, European Medicines Agency, London, UK.
authors.forename: Irmgard
authors.initials: I
authors.lastname: Eichler
mesh_terms: D015415:Biomarkers; D055808:Drug Discovery; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers