Thursday, December 2, 2021
News

Zydus Cadila seeks DCGI approval for oral pill to treat anemia

   SocialTwist Tell-a-Friend    Print this Page   COMMENT

New Delhi | Wednesday, 2021 2:45:06 AM IST
Pharma major Zydus Cadila has sought approval from the Drug Controller General of India, the apex drug regulator, for a new drug named Desidustat.

Desidustat is an oral alternative to injectable erythropoietin-stimulating agents (ESAs) for the treatment of anemia caused due to chronic kidney disease.

Zydus said in a statement that it has submitted the new drug application (NDA) for Desidustat to the DCGI.

Desidustat is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) for treatment of anemia in patients with chronic kidney disease.

The NDA for Desidustat is based on positive data from DREAM-ND and DREAM-D Phase 3 trials in patients with chronic kidney disease.

Desidustat met its primary efficacy endpoint in both Phase 3 trials, DREAM-ND and DREAM-D, conducted in kidney patients. The data will be presented at the upcoming scientific meetings and will be published in peer-reviewed scientific journals.

"We are excited by this important milestone and thankful to all the patients, investigators, regulators and scientists, who led the discovery and development of Desidustat over the last decade. Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin-stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilisation," said Pankaj R. Patel, Chairman, Cadila.

Chronic kidney disease is a serious progressive medical condition. As per a report, 114 million people in India, 132 million in China, 38 million in the US, 21 million in Japan and 41 million people in Western Europe are estimated to be suffering from chronic kidney disease.

--IANS avr/arm

( 269 Words)

2021-11-23-20:56:04 (IANS)

 
  LATEST COMMENTS (0)
POST YOUR COMMENT
Comments Not Available
 
POST YOUR COMMENT
 
 
TRENDING TOPICS
 
 
CITY NEWS
MORE CITIES
 
 
 
MORE HEALTH NEWS
Saudi Arabia reports 1st case of Omicron...
Delhi HC pulls up govt, MCDs over failur...
6 people coming from 'at risk' countries...
ICMR approves nine systems for molecular...
NHRC takes cognizance of Muzaffarpur eye...
J&K sees 234 new cases as Covid spread c...
More...
 
INDIA WORLD ASIA
Rajasthan bags investment commitments of...
CBI arrests bank manager, one other in b...
Bihar BJP MLA questions inaction against...
Nearly 1,600 Kisan Rail services operate...
Vice Admiral Biswajit Dasgupta assumes c...
Ban air travel where Omicron is spreadin...
More...    
 
 Top Stories
Erdogan replaces Finance Minister a... 
Vice Admiral Biswajit Dasgupta assu... 
Taiwanese legislators call for boyc... 
Nearly 1,600 Kisan Rail services op... 
Hindus, Muslims, Sikhs live harmoni... 
Freight loading performance of Nort... 
Andhra seeks NITI Aayog's support f... 
"NuXious" fumes rise in China-west ...