EMA delays review of BioMarin hemophilia A candidate
In a Securities Exchange Commission filing yesterday, California-based biotech BioMarin Pharmaceutical (Nasdaq: BMRN) revealed it has received the European Medicines Agency’s Joint Assessment Report related to the EMA’s ongoing review of the company’s Marketing Authorization Application for ValRox (valoctocogene roxaparvovec) for severe hemophilia A.
The Report requests that BioMarin submits to the EMA the full 52-week results from the 134 patients in the ongoing Phase III study of valoctocogene roxaparvovec with the 6e13 vg/kg dose.
The company expects the last patient will reach 52 weeks of follow-up in November 2020, and BioMarin is working with the EMA to enable a potential submission of the requested data by the end of the first quarter of 2021.
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
Free
7 day trial access
- 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
- 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
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze