Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to […]readmore
Tags : Esbriet
Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date […]readmore
Regulatory
Genentech’s Esbriet (pirfenidone) Receives FDA’s Breakthrough Therapy Designation for Unclassifiable
Shots: The US FDA’s BT designation is based on P-II study assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing uILD, an FVC of ≥45%, DLco of ≥30%, […]readmore