MPR YIR COPD 2019

COPD, x ray

FDA Rejects NDA for Triple Combo COPD Therapy

The Food and Drug Administration has issued a complete response letter (CRL) to AstraZeneca regarding the Company’s New Drug Application (NDA) for PT010, an investigational triple combination therapy for chronic obstructive pulmonary disease (COPD). PT010 is a single inhaler, fixed-dose triple combination therapy of budesonide, an inhaled corticosteroid with glycopyrronium, a long-acting muscarinic antagonist (LAMA),…