Zydus files for Indian approval of CKD candidate desidustat
India-based Zydus Cadila, a part of Cadila Healthcare (NSE: CADILAHC), has submitted the New Drug Application (NDA) to the Drug Controller General of India for desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for treatment of anemia in patients with chronic kidney disease (CKD) who are on or not on dialysis.
Just last Saturday, Zydus Cadila announced that it had received final approval from the US Food and Drug Administration to market decitabine for injection in the USA to treat myelodysplastic syndromes, certain types of blood or bone marrow cancer.
The NDA for desidustat is based on positive data from the DREAM-ND and DREAM-D Phase III trials in patients with CKD regardless of dialysis.
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 Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze