Japanese pharmaceutical company Sumitomo Pharma has announced it received manufacturing and marketing approval for its investigational drug AMCHEPRY® for the treatment of Parkinson’s disease. As reported by Reuters, its parent company, Sumitomo Chemical, forecasts that sales of Amshepry in the 2030s will exceed 100 billion yen.
“This drug has become the world’s first regenerative and cell therapy product derived from iPS cells to receive approval,” Sumitomo Pharma stated in their announcement .
The approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on the results of an investigator-initiated clinical trial conducted at Kyoto University Hospital. The approval is conditional and time-limited. To obtain full approval, the company must confirm the product’s efficacy and safety in further post-marketing studies .
The company anticipates that this new treatment method, which is fundamentally different from traditional symptomatic medications, will become an additional therapeutic option for patients with Parkinson’s disease whose motor symptoms are not adequately controlled by existing therapies .
Furthermore, according to Reuters, another Japanese company, Cuorips, has announced it received approval for the production and sale of ReHeart, a cell sheet for cardiac muscle to treat heart failure. With these approvals, Japan has become the first country to permit the use of two therapies based on induced pluripotent stem cells (iPS cells).
Parkinson’s disease is a progressive neurodegenerative disorder and the second most common after Alzheimer’s disease. The primary noticeable symptom is slowness of movement; however, early signs can appear years before motor impairments develop. These include reduced or lost sense of smell, chronic constipation, and REM sleep behavior disorder.