EMA accepts marketing authorization application for Roxadustat
Category: #health  By Pankaj Singh  Date: 2020-05-23
  • share
  • Twitter
  • Facebook
  • LinkedIn

EMA accepts marketing authorization application for Roxadustat

Japanese pharmaceutical multinational major Astellas Pharma Inc., has announced that the marketing authorization application for anti-anemic drug Roxadustat has been accepted by the European Medicines Agency. The announcement has reportedly been made in collaboration with FibroGen, an American pharmaceutical company headquartered in San Francisco. The acceptance of this application has initiated proceedings for a payment of $130 million by Astellas to FibroGen.

For the uninitiated, Roxadustat is a new drug which can be used to treat anemia in adults suffering from chronic kidney disease. Chronic kidney disease is described to be a progressive degradation of kidney function caused by diabetes, hypertension or immune-regulated inflammations.

Experts cite that anemia in adults is the result of the kidney’s reduced ability to produce erythropoietin, a hormone responsible for producing red blood cells in the bone marrow. Anemia is said to be the leading cause of morbidity and high mortality rates in patients suffering from chronic kidney disease irrespective of being on dialysis.

Anemia associated with chronic kidney disease is highly prone to the risk of cardiovascular diseases and diminished renal outcomes. At times, it can also have negative implications on the quality of life led by the patient.

Astellas’ Roxadustat drug has been launched in Japan for the treatment of anemic patients who are on dialysis and in China for both patients on dialysis and not on dialysis.

The company has submitted a New Drug Application for non-dialysis patients to Japan’s Pharmaceutical and Medical Devices Agency. A New Drug Application has also been submitted in the United States for both patients on dialysis and not on dialysis.

About Astellas Pharma Inc.

Astellas Pharma Inc., is a multinational pharmaceutical company headquartered in Tokyo, Japan. The company specializes in the development of drugs pertaining to the fields of immunology, urology, oncology, neuroscience and metabolic diseases. The company provides drug manufacturing services through its subsidiaries in US, Europe and Asia. Kenji Yasukawa is the current President and CEO of Astellas.

Source Credits: https://www.nasdaq.com/articles/ema-accepts-astellas-marketing-authorization-application-for-roxadustat-2020-05-20



About Author

Pankaj Singh

Email: [email protected]   

Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

Read More

More News By Pankaj Singh

Appili gets FDA approval to expand the clinical trial of favipiravir
Appili gets FDA approval to expand the clinical trial of favipiravir
By Pankaj Singh

Biopharmaceutical major, Appili Therapeutics Inc., has reportedly announced that it has received the approval of the U.S. Food and Drug Administration (FDA) over its recently filed investigational new drug application ...

Saudi begins Phase III clinical trials of Chinese COVID-19 vaccine
Saudi begins Phase III clinical trials of Chinese COVID-19 vaccine
By Pankaj Singh

The Ministry of Health, Saudi Arabia, has reportedly announced that it will begin the third phase of clinical trials for a COVID-19 vaccine, as part of its cooperation with China’s CanSino Biologics Inc. The tria...

Amazon cleared by UK regulators to buy 16% stake in Deliveroo
Amazon cleared by UK regulators to buy 16% stake in Deliveroo
By Pankaj Singh

The eCommerce giant Amazon has been granted permission to purchase a minority stake in the U.K-based food delivery start-up Deliveroo. The firm was able to convince regulators that the deal would not be detrimental to ...