Otsuka Ends Partnership With Akebia Over CRL-Related CKD Anemia Drug
Otsuka Pharmaceutical said it is ending a collaboration with Akebia Therapeutics over the investigational chronic kidney disease-associated anemia drug vadadustat.
Otsuka said it pulled out of the partnership because Cambridge, Mass.-based Akebia received a Complete Response Letter from the FDA in March regarding the New Drug Application. The FDA said that the data did not support a favorable benefit-risk assessment for vadadustat in dialysis and non-dialysis patients. The agency also flagged safety issues, including the risk of drug-induced liver injury.
The two companies entered into their partnership in December 2016 for the U.S. market and expanded it in April 2017 to include other parts of the world.
Otsuka Pharmaceutical Co., Ltd., is a pharmaceutical company headquartered in Tokyo, Osaka and Naruto, Japan. The company was established August 10, 1964. Parent company Otsuka Holdings Co. Ltd. joined the Tokyo Stock Exchange through an initial public offering (IPO) on December 15, 2010, at which time Otsuka Holdings was Japan's No.2 drug maker by sales after industry leader Takeda Pharmaceutical Company. The IPO debuted at $2.4 billion, making it the largest for a pharmaceutical company up to that time.
May 17, 2022
