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Orkambi Efficacy Sways FDA Panel Despite Uncertainty Over Lumacaftor’s Role

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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