FibroGen and AstraZeneca's roxadustat to face FDA AdCom

5 March 2021

USA-based FibroGen (Nasdaq: FGEN) and its partner, AstraZeneca (LSE: AZN), have revealed that the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration will hold an advisory committee (AdCom) meeting to review the new drug application for roxadustat in the USA. The companies have not received a confirmed AdCom meeting date from the FDA.

“While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the US as soon as possible,” said Enrique Conterno, chief executive of FibroGen. “We continue to be confident in the efficacy and safety profile of this potential new medicine based on positive results from a global Phase III program encompassing more than 8,000 patients.”

Roxadustat has been approved in China, Japan and Chile for the treatment of anemia of CKD in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.

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