Celtaxsys To Hash Out Phase III Cystic Fibrosis Endpoints With US FDA
Private start-up's acebilustat failed to improve lung function in Phase II, but the anti-inflammatory showed large numerical reductions in pulmonary exacerbations, which can be fatal.
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Vertex continued its growth story in cystic fibrosis during 2017. It also chose a pair of candidates for Phase III triple combination development, threatening to virtually seal off market entry to others.
Top-line results from two Phase III studies indicate Vertex’s potential new combination cystic fibrosis therapy, tezacaftor plus ivacaftor, is effective and well tolerated in certain cystic fibrosis patients, and could become the backbone of a triple combination therapy for a wider patient group.
Pulmonary-allergy drugs panel endorses approval of Vertex’s lumacaftor/ivacaftor fixed-dose combination for cystic fibrosis and suggests the question of whether the combination would be more or less effective than ivacaftor monotherapy is not relevant.