The Japanese Ministry of Health has given the green light for the commercial use of the world's first regenerative medicine drugs based on induced pluripotent stem cells (iPS). These drugs are intended for the treatment of severe heart failure and Parkinson's disease, as reported by Kazinform, citing SCMP.
Two drugs have received approval: ReHeart, designed to assist with ischemic cardiomyopathy, and Amchepry, used to correct degenerative changes associated with Parkinson's disease.
Shinya Yamanaka, Nobel Prize laureate and honorary director of the iPS Cell Center at Kyoto University, expressed joy over this achievement, noting that it is a significant step towards the practical application of the technology 20 years after its discovery.
The technology underlying the ReHeart drug involves the use of cardiomyocytes derived from iPS cells. Sheets created from these cells are applied to the patient's heart to stimulate angiogenesis and restore organ function. Clinical trials showed a reduction in shortness of breath and improved physical endurance among participants.
As for Amchepry, its application involves the introduction of precursor cells into the brain that begin to produce dopamine. During the trials, six out of seven patients experienced partial restoration of motor functions.
It is important to note that the approval has a limited duration of seven years. The drugs can only be used in small clinical groups. Full implementation is possible only after confirming their safety and efficacy within the established timeframe.
Sales of the new drugs are expected to begin by the end of this year, following the completion of pricing processes and inclusion in the health insurance system. Cuorips has already announced its plans to start sales this year.
