The Japanese government on Friday conditionally approved the commercialization of two regenerative medicine products prepared from induced pluripotent stem cells, marking the world’s first.
The two iPS-derived drugs are ReHeart, developed by Cuorips Inc. to treat patients with severe heart failure stemming from ischemic cardiomyopathy, and Amchepry, produced by Sumitomo Pharma Co. and Racthera Inc. to treat Parkinson’s disease, a progressive neurodegenerative disorder.
With their prices and insurance application still needing further discussions, treatment using the drugs is expected to begin in summer at the earliest.
ReHeart is expected to cost over 10 million yen ($63,500), and Amchepry will also be expensive.
Health, Labor and Welfare Minister Kenichiro Ueno welcomed the practical use of the products made in Japan.
“I hope they will save patients not only in Japan but also all around the world,” he said.
Despite the limited number of clinical trial cases, the health ministry took advantage of a system for early conditional approval so long as the drugs’ safety is confirmed and their efficacy is presumed.
ReHeart and Amchepry need to prove their efficacy within seven years through treatment of patients to earn a full-fledged approval.
Induced pluripotent stem cells, or iPS cells, possess the ability to differentiate into almost any human cell type and proliferate virtually indefinitely, according to Kyoto University’s Center for iPS Cell Research and Application.
They were generated by Shinya Yamanaka, director emeritus and professor at the center, who announced the generation of mouse iPS cells in 2006 and human iPS cells in 2007. He won the Nobel Prize in physiology or medicine in 2012.
