Compassionate Use Questions Could Arise At FDA/Patient Meeting On IPF Treatments
This article was originally published in The Pink Sheet Daily
InterMune already has made its pirfenidone available to idiopathic pulmonary fibrosis patients on a compassionate-use basis.
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InterMune’s pirfenidone and Boehringer Ingelheim’s nintedanib are neck-and-neck in the race to be the first drug interventions in the U.S. for the fatal lung disease. Phase III data from both drugs were presented at the American Thoracic Society meeting and published in the NEJM May 18.
Conflict among groups with conditions both included and not included in the preliminary list of public meeting topics prompts FDA to reiterate that the diseases will be selected because better clinical measures are needed, not because the agency will prioritize them over others.
PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.