Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD).
Today the company announced the completion of its New Drug Application (NDA) with the US Food and Drug Administration (FDA), as a result of which Italfarmaco will receive priority review with a Prescription Drug User Fee Act (PDUFA) goal date set for December 21, 2023.
The NDA submission is grounded in Italfarmaco’s completed clinical development program which demonstrated positive results assessing the efficacy and safety of givinostat in patients with DMD.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze