The U.S. Food and Drug Administration (FDA) is giving the go-ahead to Otsuka’s tolvaptan, a drug for people with polycystic kidney disease (PKD). PKD is a life-threatening inherited disorder in which clusters of cysts develop primarily within the kidneys, causing them to enlarge and lose function over time.
The FDA’s go-ahead—which previously had been turned down in 2013—was sparked by positive results from a more recent clinical study conducted using the drug. The drug was previously approved in 2015 in Europe, where it sells under the name of Jinarc. According to Otsuka, it is the first treatment to slow decline in kidney function in individuals with PKD. The company also states that it anticipates the US approval of tolvaptan to increase its sales this year up to $81 billion.
Otsuka Pharmaceutical Company is a global health care company that manufactures and markets innovative products. Otsuka focuses on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
This was reported by PMLive on April 25, 2018.
Contact Information: Otsuka America Pharmaceutical, Inc. 2440 Research Boulevard, Rockville, Maryland 20850; (301) 424-9055; Website: www.otsuka-us.com