PTC Therapeutics to re-file for Canadian approval of Translarna with new data

14 March 2016

US drugmaker PTC Therapeutics (Nasdaq: PTCT) says it intends to submit the results of the recently completed Phase III ACT DMD study for review by drugs regulatory Health Canada as part of the New Drug Submission (NDS) for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD).

In order to submit this additional data for review, PTC will withdraw the current NDS from Health Canada and resubmit the NDS with the ACT DMD results. As a result, the company no longer expects Health Canada review of the NDS in the first half of 2016.

Although Translarna has received approval in Europe, just last month the US Food and Drug Administration issued a Refuse to File letter regarding the company’s New Drug Application for the treatment of nmDMD.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

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