The move makes Alofisel (darvadstrocel) the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to be authorized in that Asia country, which has just over 70,000 people living with CD.
The approval is based on data from two trials, the Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe and Israel.
Alofisel provides a potential cell-mediated closure option for patients who have shown an inadequate response to at least one existing medicinal treatment.
In addition to the symptoms of CD, people living with the disease may experience complex perianal fistulas, which can cause intense pain, bleeding, swelling, infection, and anal discharge. Despite medical and surgical advancements, complex perianal fistulas in CD remain challenging for clinicians to treat.
Alofisel, by exhibiting immunomodulatory and local anti-inflammatory effects at the site of inflammation, provides a new treatment option with the potential of cell-mediated closure for complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease who have shown an inadequate response to at least one existing medicinal treatment, said the Japan headquartered Takeda.
Approvals beyond Japan
The therapy is also approved in the EU, Israel, Switzerland and the UK for the treatment of complex perianal fistulas. In 2019, it received a Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for complex perianal fistulas in adults with CD.
It is a made to order treatment that must be administered within 72 hours of manufacture.
Takeda has established a manufacturing and logistics system in Japan that enables delivery to medical institutions nationwide under strict temperature control.
Meeting sustainability goals in manufacturing
Separately, last week saw Takeda flag ambitious environmental pledges, breaking ground on a new $14m expansion of its Singapore manufacturing operations, marking the first ‘net zero carbon emissions’ building to be part of its global network.
The building will meet Singapore’s Green Mark Zero Energy certification guidelines and is aligned with the UN’s Sustainable Development Goals (SDGs). The company expects the facility to be ready for occupancy sometime next year.
It is the first of its kind investment within the biotechnology industry in Singapore.
The project will include the installation of over 660 solar photo voltaic (PV) panels to fully offset the building’s energy consumption, CO2 sensors to regulate fresh air demand, a hybrid AC system with assistance of ceiling fans and thermal diffusers to optimize energy usage and improve air circulation and air flow to ensure user well-being. Additionally, the building also utilizes rainwater harvesting and the use of green concrete.
